Wondzorg bij acute (traumatische en chirurgische) wonden

Initiatief: NVVH Aantal modules: 27

Wondmateriaal voor een donorplaats wond

Uitgangsvraag

Wat is het optimale wondmateriaal voor een donorplaats wond na split-skin grafting?

Aanbeveling

Gebruik een hydrocolloïd verband om snelle genezing met weinig pijn tijdens de verbandwissels te bewerkstelligen. Als tweede keus kan een folie worden gebruikt.

Overwegingen

Voor- en nadelen van de interventie en de kwaliteit van het bewijsmateriaal

In de vorige richtlijn acute wond, gepubliceerd in 2013, wordt aanbevolen om donorplaats wonden te bedekken met een hydrocolloïdverband om snelle genezing te bewerkstelligen. Als alternatief wordt een folieverband aangeraden als een goede tweede keus.

 

Hydrocolloïd

Er is literatuuronderzoek uitgevoerd naar de effectiviteit van hydrocolloïdverband ten opzichte van verschillende andere wondmaterialen. Op basis van de conclusies uit de literatuursamenvatting van de cruciale uitkomstmaten (duur van de wondgenezing) lijkt het gebruik van hydrocolloïdverband te resulteren in een kortere genezingsduur (8 tot 19 dagen) van de wond in vergelijking met andere wondbedekkers (10 tot 32 dagen). De bewijskracht hiervoor is laag.

 

Op basis van de belangrijke uitkomstmaten (wondinfecties, kwaliteit van het litteken en bijwerkingen) kan niet met zekerheid gezegd worden dat het gebruik van een hydrocolloïdverband in betere of slechtere uitkomsten resulteert dan andere wondbedekkers. De kwaliteit van het bewijsmateriaal hiervoor is zeer laag. Dit komt voornamelijk door het lage aantal geïncludeerde patiënten in de trials, het kleine aantal events en omdat blindering niet mogelijk was. Wat ook meespeelt is het feit dat wondinfecties en bijwerkingen überhaupt weinig voorkomen bij donorplaats wonden (Brölmann, 2013; Macharia, 2019; Solank, 2012; Tan, 1993), logischerwijs is het dan lastiger om verschillen aan te tonen tussen de verschillende wondbedekkers. Er waren geen studies gevonden die de pijn tijdens de verbandwissels hebben onderzocht. Wel wordt in de literatuur vermeld dat patiënten over het algemeen weinig pijn ervaren tussen de verbandwissels door bij gebruik van verschillende wondmaterialen (Brölmann, 2013; Feldman, 1991; Macharia, 2019).

 

Andere wondbedekkers

De werkgroep heeft daarnaast aanvullend gekeken naar andere wondmaterialen naast hydrocolloïd. Uit deze aanvullende screening zijn vijf systematische reviews uit de literatuur naar voren gekomen (Abul, 2020; Brewer, 2020; Liang, 2019; Rahman, 2020; Serebrakian, 2018).

Abul (2020) onderzocht het verschil in effect van een biologisch amnionmembraan ten opzichte van conventionele, niet-biologische wondbedekkers, zoals paraffine gaas, polyurethaan schuimverband of een folieverband. De auteurs concludeerden dat een biologisch amnionmembraan een betere wondgenezing geeft vergeleken met conventionele wondbedekkers.

 

Brewer (2020) onderzocht in de systematische review en meta-analyse het verschil in effect van bloedplaatjesrijk plasma ten opzichte van niet biologische wondbedekkers. Brewer (2020) concludeerde dat bloedplaatjesrijk plasma leidt tot betere wondgenezing dan een niet-biologische wondmaterialen. Er is echter een bescheiden hoeveelheid bewijsmateriaal beschikbaar, waardoor de bevindingen moeten worden onderbouwd met meer en grote gerandomiseerde studies.

 

Rahman (2020) beschreef in een systematische review het verschil tussen biologische en niet-biologische wondmaterialen bij patiënten met split-skin donorplaats wonden. Zij concludeerden dat biologische wondmaterialen, zoals amnionmembranen, bloedplaatjesrijk plasma, honing en keratinocyten de snelheid van wondgenezing verhogen, maar geen duidelijk effect hebben op het infectierisico of pijn tijdens verbandwisselingen.

 

Liang (2019) onderzocht het verschil in effect van een amnionmembraan ten opzichte van niet biologische wondbedekkers. Liang (2019) concludeerde dat een amnionmembraan leidt tot betere uitkomsten, zoals wondgenezing, pijn en infecties dan een niet-biologische wondmaterialen. De kwaliteit van de geïncludeerde studies in de systematische review is echter laag. Er zijn grote gerandomiseerde studies van goede kwaliteit nodig om de bevindingen te bevestigen.

 

Serebrakian (2018) onderzocht het verschil tussen vochtige en niet-vochtige wondbedekkers en concludeerde dat vochtige wondbedekkers superieur zijn ten opzichte van niet-vochtige wondbedekkers met betrekking tot pijn en wondgenezing.

 

Samenvattend

De werkgroep concludeert dat hydrocolloïd wondbedekkers nog steeds zijn aan te raden (Brölmann, 2013; Macharia, 2019; Shaileshkumar, 2012). Daarnaast zijn er verschillende alternatieven beschikbaar zoals biologische wondbedekkers of wondbedekkers die een vochtig milieu creëren, die niet zijn vergeleken met hydrocolloïd wondbedekkers maar wel overwogen kunnen worden.

 

Waarden en voorkeuren van patiënten (en eventueel hun verzorgers)

Pijn tijdens de verbandwissels en het doorlekken van divers wondmateriaal is vaak van invloed op de patiënttevredenheid. Het zou dus voorkeur kunnen hebben om het aantal verbanwissels te beperken. Pijn bij verbandwissels wordt niet alleen beïnvloed door het verbandmateriaal maar ook door de hoeveelheid exsudaat, omgeving waarin de patiënt zich bevindt, uitleg, expertise, adherente verbandsoorten of door overige pijnmedicatie. Er zijn meerdere wondbedekkers waarbij minder pijn ervaren wordt, waaronder hydrocolloïd en biologische verbandmiddelen.

 

Kosten (middelenbeslag)

De kosten van verschillende wondmaterialen zijn lastig te bepalen aangezien deze afhangen van onder andere de (grootte van de) wond en situatie van de patiënt. Niet alleen de materialen zelf, maar ook de verbandwisselfrequentie en personele kosten kunnen verschillen tussen de materialen. Biologische producten zijn een stuk duurder in gebruik, terwijl (nog) niet is aangetoond dat deze producten beter zijn dan hydrocolloïd. Aangezien het categorie wonden 1 en 2 betreffen en binnen 3 weken geheeld zijn, komen patiënten normaliter niet in aanmerking voor een vergoeding van hun zorgverzekeraar. Dus eventuele kosten van verbandmiddelen moeten worden besproken met de patiënt.

 

Aanvaardbaarheid, haalbaarheid en implementatie

De deskundigheid voor het gebruik van gaasverbanden en moderne materialen is voor beide wondsoorten van groot belang voor een effectieve wondgenezing.

 

Er zijn heel veel wondbedekkende producten op de markt, ook voor donorplaatsen. Dit stelt hoge eisen aan de kennis bij de professional. Beperking van het lokale arsenaal tot enkele van de bovengenoemde effectieve producten is daarom aan te bevelen. Wondbedekkers verschillen in absorberend vermogen en kunnen dus langer blijven zitten naarmate het absorberend vermogen toeneemt. Het op onjuiste wijze aanbrengen van een verbandmateriaal kan leiden tot complicaties, zoals pijn, blaarvorming, bloeding of maceratie.

 

Er zijn veel soorten wondbedekkers en de beschikbaarheid is groot. Dit komt voornamelijk door de marketing van de producenten. Zij hebben alleen een CE-keurmerk nodig om hun middel op de markt te brengen. Bewijs van effectiviteit en veiligheid hoeven niet te worden aangetoond. 

 

Beschikbare evidence suggereert dat biologische wondbedekkers kunnen helpen bij een snellere genezing van donorplaats wonden. Deze producten zijn echter kostbaar en niet vrij beschikbaar en daardoor niet algemeen aan te bevelen.

 

Rationale van de aanbeveling: weging van argumenten voor en tegen de interventies.

Bij donorplaats wonden na een split-skin graft adviseert de werkgroep om deze te bedekken met een hydrocolloïd wondbedekker. Indien een hydrocolloïd niet beschikbaar is zijn er meerdere alternatieven beschikbaar, waarbij een wondbedekker die een vochtig milieu creëert de voorkeur heeft boven een wondbedekker die dit niet doet en een biologische wondbedekker de voorkeur heeft boven een niet-biologische, maar de eerstgenoemde is niet vrij beschikbaar en duur. Er zijn geen studies waarbij bovenstaande alternatieven zijn vergeleken met hydrocolloïd.

Onderbouwing

Op dit moment is er geen gouden standaard beschreven voor wat betreft het optimale wondmateriaal voor een donorplaats wond na split-skin grafting. Er heerst dan ook nog veel praktijkvariatie rondom het gebruik van wondmaterialen op dit soort wonden. De huidige aanbeveling (level 1b, RCT), op basis van beschikbare evidentie, is om bij donorplaats wonden een hydrocolloïdverband te gebruiken om snelle en comfortabele genezing te bewerkstelligen.

Healing time (crucial)

Low

GRADE

Hydrocolloïd dressings may reduce healing time when compared with antimicrobial hydrofiber, silicone, film, (paraffin) gauze, alginate, or biosynthetic dressings in patients with split skin graft procedures for donor site wounds.

 

Sources: (Brölmann, 2013; Leicht, 1989; Porter, 1991; Smith, 1993; Solanki, 2012)

 

Wound infection (important)

Very low GRADE

The evidence is very uncertain about the effect of hydrocolloid dressings on wound infections compared with other dressings (for example antimicrobial hydrofiber, silicone, film, (paraffin) gauze, alginate, antimicrobial foam, biosynthetic or hydrogel dressings in patients with split skin graft procedures for donor site wounds.

 

Sources: (Brölmann, 2013; Macharia,2019; Solanki, 2012; Tan, 1993)

 

Scar quality (important)

Very low GRADE

The evidence is very uncertain about the effect of hydrocolloid dressings on scar formation compared with other dressings (e.g. antimicrobial hydrofiber, silicone, film, (paraffin) gauze, or alginate dressings in patients with split skin graft procedures for donor site wounds.

 

Sources: (Brölmann, 2013)

 

Adverse events (important)

Very low GRADE

The evidence is very uncertain about the effect of hydrocolloid dressings on adverse events compared with other dressings (for example antimicrobial hydrofiber, silicone, film, (paraffin) gauze, alginate, antimicrobial foam, biosynthetic or hydrogel dressings in patients with split skin graft procedures for donor site wounds.

 

Sources: (Brölmann, 2013)

 

Pain, frequency of dressing changes and patient satisfaction (important)

-

GRADE

No evidence was found regarding the effect of hydrocolloïd dressings on pain, frequency of dressing changes, and patient satisfaction when compared with other dressings in patients with split skin graft procedures for donor site wounds.

Summary of literature

Description of studies

The trial of Macharia (2019) compared the effectiveness of four different dressing materials, namely, hydrocolloids (DUODERM™), paraffin gauze (BACTIGRAS™), antimicrobial hydrofiber (Aquacel™) dressings, and antimicrobial biguanide foam (KENDAL™) in patients with donor site wounds. In total, 88 patients were randomized into four groups (n=22 per group). The maximum length of follow-up was ten days after randomization. The reported outcome measure in the trial was: wound infection.

 

The trial of Brölmann (2013) investigated which dressing material was best for healing donor site wounds after split-skin grafting. Brölmann (2013) compared alginate dressings, film dressings, paraffin gauze dressings, hydrocolloid dressings, hydrofiber dressings, and silicone dressings. In total, 289 patients were included in the study and randomly allocated to one of the six dressing groups. The maximum length of follow-up was twelve weeks. The reported outcome measures in the study were: healing time, wound infection, scar quality, and adverse events.

 

The trial of Solanki (2012) compared the efficacy of a new, purpose-designed biosynthetic material (AWBAT-D™) with hydrocolloid (DUODERM™) dressings in patients with donor site wounds after split-skin grafting procedures. In total, sixteen patients were included in the study and randomly allocated to either hydrocolloid dressings or biosynthetic dressing. The maximum length of follow-up was until complete wound healing. The reported outcome measures in the study were: healing time and wound infection.

 

The trial of Tan (1993) compared hydrocolloid dressings with hydrogel (Zenoderm™) in the treatment of split skin graft donor areas. In total, 64 patients were randomly assigned into two groups (n=34 in the hydrocolloid group and n=30 in the hydrogel group). The maximum length of follow-up was ten days after surgery. The reported outcome measures in the trial were: wound infection and costs.

 

The trial of Smith (1993) compared an occlusive hydrocolloid dressing with a fine mesh gauze (bismuth tribromophenate-impregnated) dressing in patients who underwent skin-graft donor site procedures. In total, 30 patients were randomized into two groups (n=14 in the hydrocolloid group and n=16 in the fine mesh gauze group). The maximum length of follow-up was until complete wound healing. The reported outcome measure in the trial was: healing time.

 

The trial of Feldman (1991) compared hydrocolloid dressings with Biobrane™ or a fine mesh gauze impregnated with three percent bismuth tribromophenate (Xeroform™) in patients who underwent split-thickness skin graft donor site procedures. In total, 30 patients were randomized into three groups (n=10 in the hydrocolloid group, n=10 in the Biobrane™ group, and n=10 in the Xeroform™ group). The maximum length of follow-up was until complete wound healing. The reported outcome measure in the trial was costs.

 

The trial of Porter (1991) compared the performances of hydrocolloid dressings and alginate dressings in patients who underwent split-skin graft donor site procedures. In total, 65 patients were randomized into two groups (n=31 in the hydrocolloid group and n=34 in the alginate group). The maximum length of follow-up was until complete wound healing. The reported outcome measure in the trial was healing time.

 

The trial of Leicht (1989) compared hydrocolloid dressings with film (Omiderm™) dressings in patients who underwent split-skin graft procedures. In total, 8 patients were included in the study who were their own control group. The maximum length of follow-up was until complete wound healing. The reported outcome measure in the trial was healing time.

 

Results

Healing time (crucial)

Healing time was reported in six studies (Brölmann; Leicht, 1989; Porter, 1991; Smith, 1993; Solanki, 2012). As these studies reported different comparisons, we present the results separately.

 

Hydrocolloid dressing versus antimicrobial hydrofiber dressings

Brölmann (2013) reported a mean ± SD time to wound healing of 19.4 ± 11.5 days for treatment with hydrocolloid dressings, compared to 26.0 ± 18.2 days for treatment with antimicrobial hydrofiber dressings in patients undergoing split-thickness skin graft. The mean difference (MD) between these two treatments is 6.60 days (95% CI 0.48 to 12.72) in favor of the treatment with hydrocolloid dressings. This means that wounds in patients who received a hydrocolloid dressing heal 6.6 days faster in comparison with antimicrobial hydrofiber dressings. This is considered clinically relevant. 

 

Hydrocolloid dressings versus silicone dressings

Brölmann (2013) reported a mean ± SD time to wound healing of 19.4 ± 11.5 days for treatment with hydrocolloid dressings, compared to 29.2 ± 22.5 days for treatment with silicone dressings in patients undergoing split-thickness skin graft. The mean difference (MD) between these two treatments is 9.40 days (95% CI 2.67 to 16.93) in favor of the treatment with hydrocolloid dressings. This means that wounds in patients who received a hydrocolloid dressing heal 9.4 days faster in comparison with silicone dressings. This is considered clinically relevant.

 

Hydrocolloid dressings versus film dressings

Brölmann (2013) reported a mean ± SD time to wound healing of 19.4 ± 11.5 days for treatment with hydrocolloid dressings, compared to 32.9 ± 6.2 days for treatment with film dressings in patients undergoing split-thickness skin graft. The difference between these two treatments is 13.50 days (95% CI 9.84 to 17.16) in favor of the treatment with hydrocolloid dressings. This means that wounds in patients who receive a hydrocolloid dressing heal 13.5 days faster in comparison with film dressings. This is considered clinically relevant.

Leicht (1989) reported a mean ± SD time to wound healing of 7.63 ± 1.06 days for treatment with hydrocolloid dressings, compared to 10.63 ± 1.3 days for treatment with film dressings in patients who underwent split-skin graft. The mean difference (MD) between these two treatments is 2.9 (95% CI 1.70 to 4.24) in favor of the treatment with hydrocolloid dressings. This means that wounds in patients who receive a hydrocolloid dressing heal 2.9 days faster in comparison with film dressings. This is considered clinically relevant.

 

Hydrocolloid versus (paraffin) gauze dressings

Brölmann (2013) reported a mean ± SD time to wound healing of 19.4 ± 11.5 days for treatment with hydrocolloid dressings, compared to 27.9 ± 17.1 days for treatment with gauze dressings in patients undergoing split-thickness skin graft. The mean difference (MD) between these two treatments is 8.50 days (95% CI 2.77 to 14.23) in favor of the treatment with hydrocolloid dressings. This means that wounds in patients who receive a hydrocolloid dressing heal 8.5 days faster in comparison with gauze dressings. This is considered clinically relevant. 

 

Hydrocolloid dressings versus alginate dressings

Brölmann (2013) reported a mean ± SD time to wound healing of 19.4 ± 11.5 days for treatment with hydrocolloid dressings, compared to 27.1 ± 14.4 days for treatment with alginate dressings in patients undergoing split-thickness skin graft. The mean difference (MD) between these two treatments is 7.70 days (95% CI 2.40 to 13.00) in favor of the treatment with hydrocolloid dressings. This means that wounds in patients who received a hydrocolloid dressing heal 7.7 days faster in comparison with alginate dressings. This is considered clinically relevant.

 

The study of Porter (1991) reported a mean (range) time to wound healing of 10.0 (6 to 15) days for treatment with hydrocolloid dressings, compared to 15.5 (7 to 35) days for treatment with alginate dressings in patients undergoing split-skin graft procedures. The difference between these two treatments is 5.5 days in favor of the treatment with hydrocolloid dressings. This means that wounds in patients who received a hydrocolloid dressing heal 5.5 days faster in comparison with alginate dressings. This is considered clinically relevant.

 

Hydrocolloid dressing versus biosynthetic wound material

Solanki (2012) reported a median time to wound healing of 11 days for treatment with hydrocolloid dressings, compared to 17 days for treatment with a new, purpose-designed biosynthetic wound material in patients undergoing split-thickness skin graft. This means that wounds in patients who received a hydrocolloid dressing heal 6 days faster in comparison with new, purpose-designed biosynthetic wound material dressings. This was considered clinically relevant.

 

Wound infection (important)

The outcome measure wound infection was reported in four studies (Brölmann, 2013; Macharia, 2019; Solanki, 2012; Tan, 1993). As these studies reported different comparisons, we present the results separately.

 

Hydrocolloid dressings versus antimicrobial hydrofiber dressings

Brölmann (2013) reported an incidence of 1/49 (2%) wound infections at 12 weeks follow-up in treatment with hydrocolloid dressings, compared to 7/47 (14.9%) for treatment with antimicrobial hydrofiber dressings in patients undergoing split-thickness skin graft. This resulted in a relative risk (RR) of 0.14 (95% CI 0.02 to 1.07) and a risk difference (RD) of 0.13 (95% CI -0.02 to 0.24), in favor of treatment with hydrocolloid dressings. This means that treatment with hydrocolloid dressings results in 13% less wound infections. This was considered clinically relevant.

 

Macharia (2019) did not report any wound infections in both groups.

 

Hydrocolloid dressings versus silicone dressings

Brölmann (2013) reported an incidence of 1/49 (2%) wound infections at 12 weeks follow-up in treatment with hydrocolloid dressings, compared to 2/48 (4.2%) for treatment with silicone dressings in patients undergoing split-thickness skin graft. This resulted in a relative risk (RR) of 0.49 (95% CI 0.05 to 5.23); a risk difference (RD) of 0.02 (95% CI -0.05 to 0.09), in favor of treatment with hydrocolloid dressings. This was not considered clinically relevant.

 

Hydrocolloid dressings versus film dressings

Brölmann (2013) reported an incidence of 1/49 (2%) wound infections at 12 weeks follow-up in treatment with hydrocolloid dressings, compared to 8/49 (16.3%) for treatment with film dressings in patients undergoing split-thickness skin graft. This resulted in a relative risk (RR) of 0.13 (95% CI 0.02 to 0.96); a risk difference (RD) of 0.14 (95% CI 0.03 to 0.25); a number needed to treat (NNT) of 7 (95%CI 4 to 33), in favor of treatment with hydrocolloid dressings. This means that treatment with hydrocolloid dressings results in a 14.1% reduction of wound infections. This was considered clinically relevant.

 

Hydrocolloid versus (paraffin) gauze dressings

Brölmann (2013) reported an incidence of 1/49 (2%) wound infections at 12 weeks follow-up in treatment with hydrocolloid dressings, compared to 9/50 (18.0%) for treatment with (paraffin) gauze dressings in patients undergoing split-thickness skin graft. This resulted in a relative risk (RR) of 0.11 (95% CI 0.01 to 0.86); a risk difference (RD) of 0.16 (95% CI 0.05 to 0.27); a number needed to treat (NNT) of 7 (95%CI 4 to 20), in favor of treatment with hydrocolloid dressings. This means that treatment with hydrocolloid dressings results in a 16% reduction of wound infections. This was considered clinically relevant.

 

Macharia (2019) reported wound infection at ten days follow-up and reported an incidence of 0% for treatment with hydrocolloid, compared to 83% for treatment with paraffin gauze dressings. A relative risk could not be calculated. The risk difference (RD) is 83%, a number needed to treat (NNT) of 2. This means that wounds in patients who received a hydrocolloid dressing have 83% less wound infections at ten days follow-up in comparison with paraffin gauze dressings. This was considered clinically relevant.

 

Hydrocolloid dressings versus alginate dressings

Brölmann (2013) reported an incidence of 1/49 (2%) wound infections at 12 weeks follow-up in treatment with hydrocolloid dressings, compared to 0/45 (0%) for treatment with alginate dressings in patients undergoing split-thickness skin graft. This resulted in a risk difference (RD) of 0.02 (95% CI -0.03 to 0.07), in favor of treatment with alginate dressings. This was not considered clinically relevant.

 

Hydrocolloid dressings versus antimicrobial foam dressings

Macharia (2019) did not report any wound infections in both groups.

 

Hydrocolloid dressing versus biosynthetic dressings

Solanki (2012) did not report any wound infections in both groups.

 

Hydrocolloid dressing versus hydrogel

Tan (1993) reported an incidence of wound infections of 0/31 (0%) in treatment with hydrocolloid dressings, compared to 2/28 (7.1%) for treatment with hydrogel in patients undergoing split skin graft procedures at 10 days follow-up. This resulted in a risk difference (RD) of 0.07 (95% CI -0.04 to 0.18), in favor of treatment with hydrocolloid dressings. This was not considered clinically relevant.

 

Pain (important)

None of the studies that compared hydrocolloid dressings with any other dressings reported pain during dressing changes.

 

Scar quality (important)

One study reported the POSAS-score for scar quality (Brölmann, 2013) at 12 weeks follow-up. The score was reported for patients and observers separately. POSAS for observer and patient a score of 6 indicates normal skin, and 60 indicates the worst possible result. The median (IQR) POSAS scores are shown in Table 2. The differences in POSAS scores were not considered clinically relevant for hydrocolloïd dressings compared to the other dressings.

 

Table 2. Patient and observer POSAS-score in the study of Brölmann (2013) for scar quality in patients with donor

site wounds after split-skin grafting. Median (IQR) POSAS scores are reported.

Author

Hydrocolloid

dressings

Antimicrobial hydrofiber

dressings

Silicone dressings

Film dressings

(Paraffin) gauze

dressings

Alginate 

dressings

Patient scores

10 (8 to 12)

10 (7 to 15)

11 (9 to 14)

14 (11 to 15)

11 (8 to 14)

10 (7 to 13)

Observer scores

10 (8 to 12)

11 (9 to 15)

11 (8 to 13)

11 (10 to 15)

12 (8 to 14)

11 (8 to 14)

 

Frequency of dressing changes (important)

None of the studies that compared hydrocolloid dressings with any other dressings reported this outcome measure.

 

Adverse events (important)

The outcome measure adverse events was reported in one study (Brölmann, 2013).

 

Hydrocolloid dressings versus antimicrobial hydrofiber dressings

Brölmann (2013) reported 1/49 (2%) adverse events at 12 weeks follow-up in treatment with hydrocolloid dressings, compared to 1/47 (2.1%) for treatment with antimicrobial hydrofiber dressings in patients undergoing split-thickness skin graft. This resulted in a risk difference (RD) of 0.001 (95% CI -0.06 to 0.06). This was not considered clinically relevant.

 

Hydrocolloid dressings versus silicone dressings

Brölmann (2013) reported 1/49 (2%) adverse events at 12 weeks follow-up in treatment with hydrocolloid dressings, compared to 3/48 (6.3%) for treatment with silicone dressings in patients undergoing split-thickness skin graft. This resulted in a risk difference (RD) of 0.04 (95% CI -0.04 to 0.12), in favor of treatment with hydrocolloid dressings. This was not considered clinically relevant.

 

Hydrocolloid dressings versus film dressings

Brölmann (2013) reported 1/49 (2%) adverse events at 12 weeks follow-up in treatment with hydrocolloid dressings, compared to 3/49 (6.1%) for treatment with film dressings in patients undergoing split-thickness skin graft. This resulted in a risk difference (RD) of 0.04 (95% CI -0.04 to 0.12), in favor of treatment with hydrocolloid dressings. This was not considered clinically relevant.

 

Hydrocolloid versus (paraffin) gauze dressings

Brölmann (2013) reported 1/49 (2%) adverse events at 12 weeks follow-up in treatment with hydrocolloid dressings, compared to 2/50 (4%) for treatment with gauze dressings in patients undergoing split-thickness skin graft. This resulted in a risk difference (RD) of 0.02 (95% CI -0.05 to 0.09), in favor of treatment with hydrocolloid dressings. This was not considered clinically relevant.

 

Hydrocolloid dressings versus alginate dressings

Brölmann (2013) reported 1/49 (2%) adverse events at 12 weeks follow-up in treatment with hydrocolloid dressings, compared to 1/45 (2.2%) for treatment with alginate dressings in patients undergoing split-thickness skin graft. This resulted in risk difference (RD) of 0.002 (95% CI -0.06 to 0.06), in favor of treatment with hydrocolloid dressings. This was not considered clinically relevant.

 

Patient satisfaction (important)

None of the studies that compared hydrocolloid dressings with any other dressings reported this outcome measure.

 

Costs (important)

The outcome measure costs was reported in two studies (Feldman, 1991; Tan, 1993). As these studies reported different comparisons, we present the results separately.

 

Hydrocolloid dressing versus hydrogel

Tan (1993) reported the total costs per dressing and reported a total cost of $36.30 for treatment with hydrocolloid dressings, compared to $16.16 for treatment with hydrogel in patients undergoing split skin graft procedures. The difference in total costs between the treatment is $20.14.

 

Hydrocolloid versus (paraffin) gauze dressings

Feldman (1991) reported the total costs per patient and reported a cost per patient of $54.88 for treatment with hydrocolloid dressings, compared to $1.16 for treatment with hydrogel in patients undergoing split skin graft procedures. The difference in total costs between the treatment is $53.72.

 

Level of evidence of the literature

Healing time

The level of evidence regarding the outcome measures healing time comes from RCTs and therefore starts high. The level of evidence was downgraded by two levels because of lack of blinding (risk of bias, 1 level); number of included patients (imprecision, 1 level). The level of evidence is low.

 

Wound infection

The level of evidence regarding the outcome measures wound infection comes from randomized clinical trials and therefore starts high. The level of evidence was downgraded by three levels because of lack of blinding (risk of bias, 1 level); number of included patients and low numbers of events (imprecision, 2 levels). The level of evidence is very low.

 

Scar quality

The level of evidence regarding the outcome measures scar formation comes from randomized clinical trials and therefore starts high. The level of evidence was downgraded by three levels because of lack of blinding (risk of bias, 1 level); number of included patients and low numbers of events (imprecision, 2 levels). The level of evidence is very low.

 

Adverse events

The level of evidence regarding the outcome measures adverse events comes from randomized clinical trials and therefore starts high. The level of evidence was downgraded by three levels because of lack of blinding (risk of bias, 1 level); number of included patients and low numbers of events (imprecision, 2 levels). The level of evidence is very low.

 

The level of evidence could not be graded for the outcome measures pain, frequency of dressing changes and patient satisfaction as these were not reported in the included studies.

Search and select

A systematic review of the literature was performed to answer the following question:

What are the beneficial effects of hydrocolloid wound dressings in patients with donor site wounds after split-skin grafting compared to other wound dressings?

 

P: patients with donor site wounds after split-skin grafting;

I: hydrocolloid wound dressings;

C: other wound dressings;

O: healing time, wound infection, pain, scar quality, frequency of dressing changes, adverse events, patient satisfaction, and costs.

 

In addition to the evidence regarding hydrocolloid wound dressings, the working group investigated whether there was strong evidence available in the literature for other wound materials. This finally resulted in five high quality systematic reviews (Abul, 2020; Brewer, 2020; Liang, 2019; Rahman, 2020; Serebrakian, 2018). These high-quality studies are described in the ’overwegingen’.

 

Relevant outcome measures

The guideline development group considered healing time as critical outcome measure for decision making; and pain, frequency of dressing changes, wound infection, adverse events, patient satisfaction, costs, and scar formation as important outcome measures for decision making.

 

A priori, the guideline development group did not define the outcome measure ‘costs’ but used the definitions used in the studies. The outcome measure ‘costs’ was only reported in a descriptive manner; clinically relevant differences and GRADE were not applied. Table 1 shows the definition of the remaining outcome measures, including the clinically relevant differences.

 

Table 1. Clinically relevant differences

Outcome measure

Measurement instrument

Statistics

Clinically relevant differences

Healing time

Time until the wound is healed (in days)

 

≥ 1 day

Wound infection

Infection rate (%)

 

Subjective: clinical suspicion

Objective: culture, biopsy, number of bacteria, CRP, BSE or infection parameters.

RR<0.9 or RR>1.1

 

Pain

During dressing change

VAS, NRS, VRS, COMFORT/FLACC

≥ 2 points

Scar quality

 

POSAS score, VSS score, MAPS, Manchester scar scale

≥ 6 points (POSAS)

Frequency of dressing changes

Until wound is healed

 

≥ 1 day dressing change

Adverse events

Caused by the intervention (%)

 

RR<0.95 or RR>1.05

 

Patient satisfaction

 

PSQ-18 and PSQ-36, COPS, NIVEL, CAHPS®, Responsiveness of health systems (WHO), QUOTE

≥ 2 points

Search and select (Methods)

For the revision of this module, the existing evidence was supplemented with published literature after 2012. The databases Medline (via OVID) and Embase (via Embase.com) were searched with relevant search terms until April 7, 2021. The detailed search strategy is depicted under the tab Methods. The systematic literature search resulted in 793 hits. Studies were selected based on the following criteria: systematic reviews, RCTs and observational studies regarding donor site wounds after split-skin grafting. Twelve studies were initially selected based on title and abstract screening. After reading the full text, four studies were excluded (see the table with reasons for exclusion under the tab Methods), and eight studies were included.

 

Results

Eight studies were included in the analysis of the literature. Important study characteristics and results are summarized in the evidence tables. The assessment of the risk of bias is summarized in the risk of bias tables.

  1. Assadian O, Arnoldo B, Purdue G, Burris A, Skrinjar E, Duschek N, Leaper DJ. A prospective, randomised study of a novel transforming methacrylate dressing compared with a silver-containing sodium carboxymethylcellulose dressing on partial-thickness skin graft donor sites in burn patients. Int Wound J. 2015 Jun;12(3):351-6. doi: 10.1111/iwj.12136. Epub 2013 Aug 6. PMID: 23919667; PMCID: PMC7950751.
  2. Brenner M, Hilliard C, Peel G, Crispino G, Geraghty R, OʼCallaghan G. Management of pediatric skin-graft donor sites: a randomized controlled trial of three wound care products. J Burn Care Res. 2015 Jan-Feb;36(1):159-66. doi: 10.1097/BCR.0000000000000161. PMID: 25185932.
  3. Brölmann FE, Eskes AM, Goslings JC, Niessen FB, de Bree R, Vahl AC, Pierik EG, Vermeulen H, Ubbink DT; REMBRANDT study group. Randomized clinical trial of donor-site wound dressings after split-skin grafting. Br J Surg. 2013 Apr;100(5):619-27. doi: 10.1002/bjs.9045. Epub 2013 Jan 24. PMID: 23460253.
  4. Brown JE, Holloway SL. An evidence-based review of split-thickness skin graft donor site dressings. Int Wound J. 2018 Dec;15(6):1000-1009. doi: 10.1111/iwj.12967. Epub 2018 Aug 17. PMID: 30117716; PMCID: PMC7949554.
  5. Ding X, Shi L, Liu C, Sun B. A randomized comparison study of Aquacel Ag and Alginate Silver as skin graft donor site dressings. Burns. 2013 Dec;39(8):1547-50. doi: 10.1016/j.burns.2013.04.017. Epub 2013 Aug 29. PMID: 23993403.
  6. Haith LR, Stair-Buchmann ME, Ackerman BH, Herder D, Reigart CL, Stoering M, Guilday RE, Patton ML, Ross KM. Evaluation of Aquacel Ag for Autogenous Skin Donor Sites. J Burn Care Res. 2015 Nov-Dec;36(6):602-6. doi: 10.1097/BCR.0000000000000212. PMID: 25501785.
  7. Higgins L, Wasiak J, Spinks A, Cleland H. Split-thickness skin graft donor site management: a randomized controlled trial comparing polyurethane with calcium alginate dressings. Int Wound J. 2012 Apr;9(2):126-31. doi: 10.1111/j.1742-481X.2011.00867.x. Epub 2011 Nov 4. PMID: 22051247; PMCID: PMC7950605.
  8. Kaiser D, Hafner J, Mayer D, French LE, Läuchli S. Alginate dressing and polyurethane film versus paraffin gauze in the treatment of split-thickness skin graft donor sites: a randomized controlled pilot study. Adv Skin Wound Care. 2013 Feb;26(2):67-73. doi: 10.1097/01.ASW.0000426715.57540.8d. PMID: 23337646.
  9. Karlsson M, Lindgren M, Jarnhed-Andersson I, Tarpila E. Dressing the split-thickness skin graft donor site: a randomized clinical trial. Adv Skin Wound Care. 2014 Jan;27(1):20-5. doi: 10.1097/01.ASW.0000437786.92529.22. PMID: 24343389.
  10. Kazanavičius M, Cepas A, Kolaityte V, Simoliuniene R, Rimdeika R. The use of modern dressings in managing split-thickness skin graft donor sites: a single-centre randomised controlled trial. J Wound Care. 2017 Jun 2;26(6):281-291. doi: 10.12968/jowc.2017.26.6.281. PMID: 28598760.
  11. Läuchli S, Hafner J, Ostheeren S, Mayer D, Barysch MJ, French LE. Management of split-thickness skin graft donor sites: a randomized controlled trial of calcium alginate versus polyurethane film dressing. Dermatology. 2013;227(4):361-6. doi: 10.1159/000356122. Epub 2013 Nov 20. PMID: 24281776.
  12. Leicht P, Siim E, Sørensen B. Treatment of donor sites--Duoderm or Omiderm? Burns Incl Therm Inj. 1989 Feb;15(1):7-10. doi: 10.1016/0305-4179(89)90060-0. PMID: 2655835.
  13. Macharia M, Nangole FW. Effects of Dressing Materials on Donor Site Morbidity: A Comparative Study at a Tertiary Hospital in Kenya. Ann Plast Surg. 2019 Jul;83(1):22-25. doi: 10.1097/SAP.0000000000001938. PMID: 31194707.
  14. McBride CA, Kimble RM, Stockton KA. Prospective randomised controlled trial of Algisite™ M, Cuticerin™, and Sorbact® as donor site dressings in paediatric split-thickness skin grafts. Burns Trauma. 2018 Nov 27;6:33. doi: 10.1186/s41038-018-0135-y. PMID: 30519595; PMCID: PMC6267093.
  15. Porter JM. A comparative investigation of re-epithelialisation of split skin graft donor areas after application of hydrocolloid and alginate dressings. Br J Plast Surg. 1991 Jul;44(5):333-7. doi: 10.1016/0007-1226(91)90144-9. PMID: 1873610.
  16. Shaileshkumar, M.E. & Mirji, Pramod & Vishwanath, G. & Basarkod, S.I. & Joshi, Chhaya & Patil, Rajani. (2012). A Clinical Trial to Assess the Efficacy of Hydrocolloid versus Paraffin Gauze Dressing for Split Thickness Skin Graft Donor Site Treatment. Journal of Clinical and Diagnostic Research. 6. 72-75.
  17. Smith DJ Jr, Thomson PD, Bolton LL, Hutchinson JJ. Microbiology and healing of the occluded skin-graft donor site. Plast Reconstr Surg. 1993 May;91(6):1094-7. doi: 10.1097/00006534-199305000-00019. PMID: 8479976.
  18. Solanki NS, Mackie IP, Greenwood JE. A randomised prospective study of split skin graft donor site dressings: AWBAT-D™ versus Duoderm®. Burns. 2012 Sep;38(6):889-98. doi: 10.1016/j.burns.2011.12.022. Epub 2012 Feb 23. PMID: 22365615.
  19. Tan ST, Roberts RH, Sinclair SW. A comparison of Zenoderm with DuoDERM E in the treatment of split skin graft donor sites. Br J Plast Surg. 1993 Jan;46(1):82-4. doi: 10.1016/0007-1226(93)90072-j. PMID: 8431749.

Systematic reviews

Study reference

Study characteristics

Patient characteristics

Intervention (I)

Comparison / control (C)

Follow-up

Outcome measures and effect size

Comments

Brown, 2018

Systematic review

 

Literature search up to 31 December 2016

 

  1. Brölmann, 2013
  2. Solanki, 2012

 

 

Study design:

Evidence-based review

 

Setting and Country:

Not specifically reported.

 

Source of funding and conflicts of interest:

Not reported.

 

Inclusion criteria SR:

  • Papers from any country of origin and published in English;
  • Full study published;
  • Human studies;
  • Study participants requiring a STSG;
  • Study participants of all ages;
  • Published after December 31, 2005;
  • Moist and non-moist dressing materials.

 

Exclusion criteria SR:

  • Papers published in a language other than English;
  • Incomplete study published;
  • Animal studies;
  • Participants not requiring a STSG;
  • Published before December 31, 2005.

 

17 studies included (15 studies in the SR of Brown were excluded for this particular guideline).

 

 

Important patient characteristics at baseline:

 

N, mean age

  1. Hydrocolloid: 61 (17)

Hydrofibre: 60 (16)

Silicone: 62 (17)

Gauze: 62 (18)

Film: 61 (18)

Alginate: 60 (18)

  1. DUODERM: 47.0 (median)

AWBAT-D: 49.5 (median)

 

Sex:

  1. Hydrocolloid: 32/49 male

Hydrofibre: 27/47 male

Silicone: 36/48 male

Gauze: 30/50 male

Film: 37/49 male

Alginate: 36/45 male

  1. Not reported.

 

Groups comparable at baseline?

Not reported.

Describe intervention:

 

  1. Hydrocolloid/ antimicrobial hydrofiber (Aquacel) dressings /silicone/film/gauze/alginate treatment. Secondary dressings were cotton gauzes and bandages to ensure equal treatment in all groups.
  2. DUODERM

Describe  control:

 

  1. Compared to each other
  2. AWBAT-D (new, purpose-designed biosynthetic material).

End-point of follow-up:

  1. 12 weeks after complete wound healing
  2. Not reported.

 

 

For how many participants were no complete outcome data available?

  1. N=10 (3.5%) dropouts. Crossover varied from three times in the hydrocolloid group to ten times in the hydrofibre group, owing to unfamiliarity with the product (14), preference of the patient (12), infection (6), leakage (3) or logistical reasons (2). The effects of these dropouts and crossovers were avoided by means of the intention-to-treat analysis.
  2. None.

 

 

Time to wound healing

Defined as

  1. full re-epithalialization fo the donor site without any remaining scabs.
  2. Time when the donor site no longer required a dressing.

 

Time to wound healing, mean (SD) (95% CI):

  1. Hydrocolloid: 19.4 (11.5)

Hydrofibre: 26.0 (18.2)

Silicone: 29.2 (22.5)

Alginate: 27.1 (14.4)

Film: 32.9 (6.2)

Gauze: 27.9 (17.1)

 

Time to wound healing, median (IQR):

  1. Hydrocolloid: 16 (12 to 21) days

Hydrofibre: 22 (15 to 27) days

Silicone: 26 (18 to 33) days

Alginate: 22 (19 to 28) days

Film: 23 (14 to 36) days

Gauze: 22 (18 to 33) days

  1. DUODERM: 11 (not reported) days

AWBAT-D: 17 (not reported) days

 

Pain (VAS 0-10), median (IQR)

  1. Hydrocolloid: 0.2 (0 to 1.1)

Hydrofibre:0.8 (0 to 1.5)

Silicone: 0.4 (0.1 to 1.1)

Alginate: 0.4 (0.0 to 1.9)

Film: 0.3 (0 to 1.0)

Gauze: 0.3 (0 to 1.5)

  1. No data

 

Adverse events

Defined as:

  1. Clinical infection

Allergic reaction

Hypergranulation

Other

  1. Not described.

 

Clinical infection, n/N (%):

  1. Hydrocolloid: 1/49 (2%)

Hydrofibre: 7/47 (15%)

Silicone: 2/48 (4%)

Alginate: 0/45 (0%)

Film: 8/49 (16%)

Gauze: 9/50 (18%)

 

Allergic reaction, n/N (%):

  1. Hydrocolloid: 0/49 (0%)

Hydrofibre: 0/47 (0%)

Silicone: 0/48 (0%)

Alginate: 0/45 (0%)

Film: 0/49 (0%)

Gauze: 0/50 (0%)

 

Hypergranulation, n/N (%):

  1. Hydrocolloid: 1/49 (2%)

Hydrofibre: 1/47 (2%)

Silicone: 2/48 (4%)

Alginate: 1/45 (2%)

Film: 1/49 (2%)

Gauze: 0/50 (0%)

 

Other, n/N (%):

  1. Hydrocolloid: 0/49 (0%)

Hydrofibre: 0/47 (0%)

Silicone: 1/48 (2%)

Alginate: 0/45 (0%)

Film: 2/49 (4%)

Gauze: 2/50 (4%)

 

Adverse events

  1. DUODERM: 0/8 (0%)

AWBAT-D: 0/8 (0%)

 

Patient satisfaction with dressing

Defined as:

  1. A score of 1 indicates very dissatisfied and 10 indicates very satisfied.
  2. Study does not report patient satisfaction

 

Patient satisfaction: Total POSAS score (patient), median (IQR)

  1. Hydrocolloid: 10 (8 to 12)

Hydrofibre: 10 (7 to 15)

Silicone: 11 (9 to 14)

Alginate: 10 (7 to 13)

Film: 14 (11 to 15)

Gauze: 11 (8 to 15)

  1. No data.

 

Patient satisfaction: Total POSAS score (observer), median (IQR)

  1. Hydrocolloid: 10 (8 to 14)

Hydrofibre: 11 (9 to 15)

Silicone: 11 (8 to 13)

Alginate: 11 (8 to 14)

Film: 11 (10 to 15)

Gauze: 12 (8 to 14)

  1. No data.

 

Patient satisfaction with dressing, median (IQR)

  1. Hydrocolloid: 7.6 (1 to 10)

Hydrofibre: 7.3 ( 4 to 10)

Silicone: 7.7 (2 to 10)

Alginate: 7.7 (4 to 10)

Film: 7.5 (1 to 10)

Gauze: 8.0 (5 to 10)

  1. No data.

 

Overall scar (patient) rating, median (IQR)

Defined as: for observer and patient a score of 1 indicates normal skin, and 10 indicates the worst possible results.

  1. Hydrocolloid: 3 (2 to 5)

Hydrofibre: 3 (2 to 5)

Silicone: 2.5 (1 to 4)

Alginate: 2 (2 to 5)

Film: 4 (1 to 4)

Gauze: 2 (2 to 5)

 

Overall scar (observer) rating, median (IQR)

  1. Hydrocolloid: 2 (2 to 3)

Hydrofibre: 2 (1 to 3)

Silicone: 2 (2 to 4)

Alginate: 3 (2 to 4)

Film: 3 (2 to 4)

Gauze: 3 (2 to 4)

  1. No data.

Author’s conclusion

 

The aim of this evidence-based review was to provide a critical review of the evidence relating to the efficacy of dressing materials in relation to healing and pain reduction. Based on the current evidence, it was determined that moist wound healing dressing products have a clear clinical advantage over non-moist dressing products in the management of split-thickness skin graft donor site wounds. This advantage relates to healing and pain/comfort. Clinicians have identified these areas to be the most important in donor site wound care. The numerous dressing types did not allow for the detection of clear trends regarding the performance of each dressing type. To date, there has been limited discussion about the influence of secondary dressings as well as methods/techniques of primary dressing use on donor site wounds. Further research is clearly warranted in this area and should aim at examining the role of secondary dressing use and using more than one primary dressing product throughout the donor site wound-healing process should be considered. As highlighted by Holden,75 it is not practical or appropriate to leave many donor site wound dressings in situ for 2 weeks.

 

 

Randomized controlled trials

Study reference

Study characteristics

Patient characteristics 2

Intervention (I)

Comparison / control (C) 3

 

Follow-up

Outcome measures and effect size 4

Comments

Macharia, 2019

Type of study:

Randomized controlled trial

 

Setting and country:

Kenyatta National Hospital, a tertiary referral and teaching hospital in Kenya.

 

Funding and conflicts of interest:

None.

Inclusion criteria:

  • Patients undergoing split-thickness skin graft.

 

Exclusion criteria:

  • Patients who were on steroids;
  • Patients who were using chemotherapeutic agents;
  • Patients with poorly controlled diabetes;
  • Patients who smoked;
  • Patients with advanced stage HIV disease.

 

N total at baseline: n=88

Paraffin gauze (BACTIGRAS): n=22

Hydrocolloid (DUODERM): n=22

Antimicrobial hydrofiber (Aquacel): N=22

Antimicrobial foam (KENDAL): n=22

 

Important prognostic factors2:

age ± SD:

The age range for the patients was 19 to 49 years, with a mean of 35.4 years.

 

Sex:

Male-to-female ratio was 5:4.

 

Other characteristics: wound types

Burns: 56/88 (63.6%)

Trauma: 27/88 (30.7%)

Chronic wounds (cellulitis): 2/88 (2.3%)

Diabetic wounds, with cellulitis: 1/88 (1.1%)

Penile wounds (necrotizing fasciitis: 1/88 (1.1%)

Postmalignant excision: 1/88 (1.1%)

 

Groups comparable at baseline?

Not clearly reported, but probably yes.

 

Describe intervention:

 

Paraffin gauze (BACTIGRAS) , hydrocolloid (DUODERM), antimicrobial hydrofiber (Aquacel), or antimicrobial foam (KENDAL) was used to cover the donor site wound.

 

 

 

Describe  control:

 

Compared with each other

Length of follow-up:

10 days

 

Loss-to-follow-up:

None.

 

 

Wound healing

Mean epithelialization score (%)

Paraffin gauze: 73.4%

Hydrocolloid: 92.2%

Aquacel: 91.4%

Kendall: 11%

 

Pain

Defined as: measured on a scale of 0 to 10 using a pain visual analog score and then further categoriezed as no pain (0), mild (1-3), moderate (4-6), and severe (7-10).

 

Day 1: mild pain

Total: 52 patients had mild pain.

Paraffin gauze: 3.8% (n=2)

Hydrocolloid: 34.6% (n=18)

Aquacel: 28.8% (n=15)

Kendall: 32.7% (n=17)

 

Day 1: severe pain, n/N (%)  

Total: 24 patients had severe pain.

Paraffin gauze: 62.5% (n=15)

Hydrocolloid: not reported.

Aquacel: not reported

Kendall: not reported.

 

Day 1: mean pain scores (no SD reported)

Paraffin gauze: 6.7

Hydrocolloid: 2.5

Aquacel: 3.7

Kendall: 3.4

 

Day 3, mild pain

Total: 68 patients had mild pain

Paraffin gauze: not reported.

Hydrocolloid: 28.8% (n=20)

Aquacel: not reported.

Kendall: 31.4% (n=21)

 

Day 3: mean pain scores (no SD reported)

Paraffin gauze: 4.8

Hydrocolloid: 1.8

Aquacel: 2.5

Kendall: 2.0

 

Day 3, severe pain

Total: 8 patients had severe pain

Paraffin gauze: 87.5%)

Hydrocolloid: not reported.

Aquacel: not reported.

Kendall: not reported.

 

Day 10, mild pain

No data.

 

Day 10, severe pain

Total: not reported.

Paraffin gauze: not reported.

Hydrocolloid: 3.4%

Aquacel: not reported.

Kendall: 69.0%

 

Day 10: mean pain scores (no SD reported)

Paraffin gauze: 5.0

Hydrocolloid: 2.2

Aquacel: 4.3

Kendall: 8.0

 

Adverse events

Defined as infection.

 

Infection incidence (%)

Total: 6.8%

Paraffin gauze: 83%

Hydrocolloid: not reported  0%?

Aquacel: 0%

Kendall: 0%

Author’s conclusion

This study demonstrated that donor site wound healing and morbidity are influenced by the dressing material. There are no 2 dressing materials with similar properties. It is thus paramount for the physician to familiarize with the qualities of a given dressing material before deciding on which to use on the donor sites. Paraffin gauze dressing had high donor site morbidities and should thus be discouraged in day-to-day use of the donor site wounds. Hydrocolloids and the hydrofiber silver dressings had the least donor site morbidities and should probably be used more routinely. Antimicrobial foam dressings on the other hand adhere to the donor site resulting in excessive pain and disrupting the healing epithelium upon removal. They

 

Cadier, 1996

Type of study:

RCT.

 

Setting and country:

Not reported.

 

Funding and conflicts of interest:

Not reported.

 

 

Inclusion criteria:

  • >12 years old;
  • Burns not exceeding 40% body surface area.

Exclusion criteria:

  • Presence of an inhalational element;
  • Clinical infection;
  • Steriod or immunosuppressant therapy.

 

N total at baseline: n=21

All patients were their own control

 

Important prognostic factors2:

age ± SD:

Not reported.

 

Sex:

Not reported.

 

Groups comparable at baseline?

Yes.

Describe intervention (treatment/procedure/test):

 

Hydrocolloid dressings

 

 

Describe  control (treatment/procedure/test):

 

Tulle dressing (Jellonet)

Length of follow-up:

14 days.

 

Loss-to-follow-up:

None.

 

Wound healing (reepithelialization), mean (SD)

 

Specific numbers not reported  hydrocolloid significantly less painful than the jellonet (P=0.056 on day 2, p<0.023 on days 4,7, and final assessment).

 

 

 

Author’s conclusion

We would strongly advocate the use of Dermasorb as a donor site dressings because it is relatively pain free and appears to promote rapid donor site re-epithelialization.

Smith (1993)

Type of study:

RCT

 

Setting and country:

 

Funding and conflicts of interest:

 

 

N total at baseline: n=30

Intervention: n=14

Control: n=16

 

Important prognostic factors2:

age ± SD:

Not reported.

 

Sex:

Not reported.

 

Groups comparable at baseline?

Unclear.

Describe intervention (treatment/procedure/test):

 

Hydrocolloid dressings

 

 

Describe  control (treatment/procedure/test):

 

Fine mesh gauze

Length of follow-up:

17 days.

 

Loss-to-follow-up:

N=3

 

Healing time, n (%)

 

5-8 days

I: 4/12 (33.3%)

C: 1/13 (7.7%)

 

9-12 days

I: 6/12 (50%)

C: 7/13 (53.8%)

 

13-17 days

I: 2/12 (16.7%)

C: 5/13 (38.5%)

 

 

 

Author’s conclusion

In conclusion, the biologic significance of this study was that the occlusive hydrocolloid dressing used was superior overall when compared with the conventional dressing. Occlusion of the wounds resulted in fewer infections, and donor sites healed more rapidly.

Tan (1993)

Type of study:

RCT

 

Setting and country:

New Zealand

 

Funding and conflicts of interest:

Not reported.

 

N total at baseline: n=60

Intervention: n=32

Control: n=28

 

 

Describe intervention (treatment/procedure/test):

 

Hydrocolloid dressings

 

 

 

Describe  control (treatment/procedure/test):

 

Zenoderm dressings

Length of follow-up:

10 days.

 

Loss-to-follow-up:

N=4

Wound healing (reepithelialization), mean (SD)

 

Complete wound healing day 10

I: 31/32 (97%)

C: 21/28 (75%)

 

Infection, n (%)

I: 0/32 (0%)

C:2/28 (7.1%)

 

 

Author’s conclusion

Two donor sites of the ZM group and none of the DE group developed clinical infection. although the incidence is not statistically significant. In neither of the two patients did the dressing slip. ZM was shown to be impermeable to various bacteria and Candida albicans (Nangia and Hung, 1990a) and it is presumed that in the absence of dressing slippage, donor site contamination occurred during harvesting of the skin graft or by haematogenous spread.

Feldman, 1991

Type of study:

RCT

 

Setting and country:

Not reported.

 

Funding and conflicts of interest:

Not reported.

 

N total at baseline: n=30

Hydrocolloid: n=10

Biobrane: n=10

Xeroform: n=10

 

Important prognostic factors2:

age ± SD:

Not reported.

 

Sex:

Not reported.

 

Groups comparable at baseline?

Unclear.

Describe intervention (treatment/procedure/test):

 

Hydrocolloid dressings

 

Describe  control (treatment/procedure/test):

 

Xeroform dressings

Length of follow-up:

Until complete wound healing

 

Loss-to-follow-up:

Not reported.

Pain, mean:

Hydrocolloid: 0.53

Xeroform: 2.41

 

Costs:

Hydrocolloid: $54.88

Xeroform: $1.16

 

Porter (1991)

Type of study:

RCT

 

Setting and country:

Not reported.

 

Funding and conflicts of interest:

Not reported.

 

N total at baseline: n=65

Intervention: n=31

Control: n=34

 

Important prognostic factors2:

age ± SD:

Not reported.

 

Sex:

30 F; 35 M

 

Groups comparable at baseline?

Yes.

 

Describe intervention (treatment/procedure/test):

 

Hydrocolloid dressings

 

 

Describe  control (treatment/procedure/test):

 

Alginate dressings

Length of follow-up:

Until complete wound healing

 

Loss-to-follow-up:

None.

Wound healing (reepithelialization), mean (SD)

 

Mean time to complete healing in days, mean (range)

I: 10.0 (6-15)

C: 15.5 (7-35)

 

 

 

 

 

Author’s conclusion

Hydrocolloid dressings have certain clear advantages in hospitalized patients. The time to complete healing of the donor area is rapid, the quality of the regenerated skin is excellent and the dressing is simple to change, due to the non-adherence between the wound and the hydrocolloid gel. As there is low friction between the wound surface and the dressing, hydrocolloid dressings are particularly suitable for awkwardly sited donor areas, which may rub against the bedclothes or have to take some of the patient’s weight. Leakage of wound exudate is the main practical problem in the clinical use of hydr eolloid dressings; this problem can be overcome for inpatients by changing the dressing but may be the cause of considerable difficulties in the management of outpatients. Alginate dressings are simple to apply in theatre and can safely be ignored until they separate spontaneously. In outpatients alginates are probably the dressing of choice, due to the absence of wound leakage.

Leicht (1989)

Type of study:

RCT

Setting and country:

Department of Plastic Surgery and Bums Unit, Kobenhavns Kommunes Hvidovre Hospital, University of Copenhagen, Denmark

 

 

Funding and conflicts of interest:

Not reported.

Inclusion criteria:

Exclusion criteria:

 

N total at baseline: n=

Intervention: n=

Control: n=

 

Important prognostic factors2:

age ± SD:

50.3 years (range 16-90)

 

Sex:

Not reported.

 

Groups comparable at baseline?

Yes.

 

Describe intervention (treatment/procedure/test):

 

Hydrocolloid dressings

 

 

Describe  control (treatment/procedure/test):

 

Omiderm dressings.

Length of follow-up:

Until complete wound healing.

 

Loss-to-follow-up:

None.

 

Wound healing (reepithelialization), mean (SD)

 

Mean healing time

I: 7.8 days (range 7-10 days)

C: 10.6 days (range 9-13 days)

 

 

 

 

Author’s conclusion

This trial with Omiderm and Duoderm dressings on comparable donor sites showed that neither fulfils the demands for the ideal temporary dressing material. Although resulting in extra dressing changes because of fluid accumulation beneath the dressing, Duoderm is recommendable since it provides fast and solid re-epithelialization and is comfortable for the patient.

 

 

Study

 

 

 

 

First author, year

Appropriate and clearly focused question?1

 

 

 

Yes/no/unclear

Comprehensive and systematic literature search?2

 

 

 

Yes/no/unclear

Description of included and excluded studies?3

 

 

 

Yes/no/unclear

Description of relevant characteristics of included studies?4

 

 

Yes/no/unclear

Appropriate adjustment for potential confounders in observational studies?5

 

 

Yes/no/unclear/not applicable

Assessment of scientific quality of included studies?6

 

 

Yes/no/unclear

Enough similarities between studies to make combining them reasonable?7

 

Yes/no/unclear

Potential risk of publication bias taken into account?8

 

 

Yes/no/unclear

Potential conflicts of interest reported?9

 

 

 

Yes/no/unclear

Brown (2018)

Yes

Yes

Yes

Yes

Not applicable

Yes

Yes

Unclear

Unclear

 

 

 

 

 

 

 

 

 

 

Study reference

 

(first author, publication year)

Was the allocation sequence adequately generated? a

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Definitely yes

Probably yes

Probably no

Definitely no

Was the allocation adequately concealed?b

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Definitely yes

Probably yes

Probably no

Definitely no

Blinding: Was knowledge of the allocated

interventions adequately prevented?c

 

Were patients blinded?

 

Were healthcare providers blinded?

 

Were data collectors blinded?

 

Were outcome assessors blinded?

 

Were data analysts blinded?

 

Definitely yes

Probably yes

Probably no

Definitely no

Was loss to follow-up (missing outcome data) infrequent?d

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Definitely yes

Probably yes

Probably no

Definitely no

Are reports of the study free of selective outcome reporting?e

 

 

 

 

 

 

 

 

 

 

 

 

Definitely yes

Probably yes

Probably no

Definitely no

Was the study apparently free of other problems that could put it at a risk of bias?f

 

 

 

 

 

 

 

 

 

 

 

Definitely yes

Probably yes

Probably no

Definitely no

Overall risk of bias

If applicable/necessary, per outcome measureg

 

 

 

 

 

 

 

 

 

 

 

 

 

 

LOW

Some concerns

HIGH

 

Macharia, 2019

Definitely yes;

 

Reason: Computer-generated randomization program.

Definitely yes;

 

Reason: Computer-generated randomization program.

Probably no;

 

Reason: Blinding of patients, data collectors, and data analysts not reported.

 

Definitely yes;

 

Reason: No loss to follow-up reported. 

Definitely yes;

 

Reason: All relevant outcomes were reported

Definitely yes;

 

Reason: No other problems noted

Some concerns (pain, healing time, infection not blinded)

Brölmann, 2013

Definitely yes;

 

Reason: This trial was stratified by centre, with a balanced allocation ratio for each treatment arm using a biased coin.

 

Definitely yes;

 

Reason: This trial was stratified by centre, with a balanced allocation ratio for each treatment arm using a biased coin.

 

Probably no;

 

Reason: Blinding of patients and care providers was obviously not possible. However, to avoid performance bias, patients were instructed only about how to use their wound dressing and wound care, without expressing any expectations regarding the effectiveness of the dressings in the trial.

Probably yes

 

Reason: Loss to follow-up was infrequent in the groups.

Definitely yes;

 

Reason: All relevant outcomes were reported

Definitely yes;

 

Reason: No other problems noted

Some concerns (pain, healing time, patient satisfaction not blinded)

Solanki, 2012

Probably yes;

 

Reason: Randomization was done using sealed envelopes opened in the operating theatre.

Reason: Randomization was done using sealed envelopes opened in the operating theatre.

Probably no;

 

Reason: Blinding of patients, data collectors, and data analysts not reported.

 

Definitely yes;

 

Reason: Loss to follow-up was infrequent in the groups.

Definitely yes;

 

Reason: All relevant outcomes were reported

Definitely yes;

 

Reason: No other problems noted

Some concerns (pain, wound size, healing time, scar formation not blinded)

Cadier, 1996

Probably yes;

 

Reason: The areas were randomly allocated, by use of sealed envelopes, to either regimen A or regimen B.

No information

Probably no;

 

Reason: Blinding of patients, data collectors, and data analysts not reported.

 

Probably yes;

 

Reason: Loss to follow-up was not reported in the groups.

Definitely yes;

 

Reason: All relevant outcomes were reported

Definitely yes;

 

Reason: No other problems noted

Some concerns (allocation concealment unclear, blinding unclear)

Tan (1993)

Probably yes;

 

Reason: The remaining 64 patients were randomly assigned to a dressing regime of either ZM or DE.

 

No information

Probably no;

 

Reason: Blinding of patients, data collectors, and data analysts not reported.

 

Probably no;

 

Reason: Two patients in the ZM group were excluded during the course of study due to violation of the protocol. A further 2 patients in this group developed clinical infection of their donor sites and had their dressing regime changed.

Definitely yes;

 

Reason: all relevant outcome measures were reported

Definitely yes;

 

Reason: No other problems noted

Some concerns (allocation concealment unclear, blinding unclear, bias due to loss to follow-up).

Smith (1993)

No information

No information

No information

Probably yes;

 

Reason: lost to follow-up almost equal in both groups.

 

Definitely yes;

 

Reason: all relevant outcome measures were reported

Definitely yes;

 

Reason: No other problems noted

Some concerns (no information regarding randomization, allocation concealment, and blinding).

Feldman (1991)

Probably yes;

 

Reason: Envelope containing one of the three dressing assignments was opened.

No information

No information

Probably yes;

 

Reason: Loss to follow-up was not reported in the groups.

Definitely yes;

 

Reason: all relevant outcome measures were reported

Definitely yes;

 

Reason: No other problems noted

Some concerns (no information regarding allocation concealment and blinding).

Porter (1991)

Probably yes;

 

Reason: Before the grafts were cut, the patients were randomised between the hydrocolloid and the alginate dressings, using cards in sealed envelopes.

No information

No information

Probably yes;

 

Reason: Loss to follow-up was not reported in the groups.

Definitely yes;

 

Reason: all relevant outcome measures were reported

Definitely yes;

 

Reason: No other problems noted

Some concerns (allocation concealment unclear, blinding unclear, bias due to loss to follow-up).

Leicht (1989)

No information

No information

No information

No information

Definitely yes;

 

Reason: all relevant outcome measures were reported

Definitely yes;

 

Reason: No other problems noted

Some concerns (no information regarding randomization, allocation concealment, and blinding).

 

Autorisatiedatum en geldigheid

Laatst beoordeeld  : 31-05-2022

Laatst geautoriseerd  : 31-05-2022

Initiatief en autorisatie

Initiatief:
  • Nederlandse Vereniging voor Heelkunde
Geautoriseerd door:
  • Nederlandse Orthopaedische Vereniging
  • Nederlandse Vereniging van Spoedeisende Hulp Artsen
  • Nederlandse Vereniging voor Dermatologie en Venereologie
  • Nederlandse Vereniging voor Heelkunde
  • Nederlandse Vereniging voor Medische Microbiologie
  • Nederlandse Vereniging voor Plastische Chirurgie
  • Verpleegkundigen en Verzorgenden Nederland

Algemene gegevens

De ontwikkeling/herziening van deze richtlijnmodule werd ondersteund door het Kennisinstituut van de Federatie Medisch Specialisten (www.demedischspecialist.nl/kennisinstituut) en werd gefinancierd uit de Stichting Kwaliteitsgelden Medisch Specialisten (SKMS). De financier heeft geen enkele invloed gehad op de inhoud van de richtlijnmodule.

Samenstelling werkgroep

Voor het ontwikkelen van de richtlijnmodule is in 2020 een multidisciplinaire werkgroep ingesteld, bestaande uit vertegenwoordigers van alle relevante specialismen (zie hiervoor de Samenstelling van de werkgroep) die betrokken zijn bij de zorg voor patiënten met acute wonden.

 

Werkgroep

  • Drs. M (Michiel) Schreve, chirurg, NVvH (voorzitter)
  • Dr. M.E.N. (Maurice) Pierie, chirurg, NVvH
  • Drs. S. (Stijn) Westerbos, orthopeed, NOV
  • Dr. M.A.M. (Miriam) Loots, dermatoloog, NVDV
  • Dr. F.E. (Fleur) Brölmann, plastisch chirurg, NVPC
  • Drs. E. (Ellie) Lenselink, wondconsulent, V&VN
  • Drs. K. (Katja) Reiding, huisarts, NHG
  • Drs. L.F.J. (Lucas) Teeven, spoedeisende hulp arts i.o., NVSHA
  • Dr. M.W.F. (Martin) van Leen, specialist ouderengeneeskunde, Verenso
  • Prof. D. T. (Dirk) Ubbink, Hoogleraar Evidence-based medicine en shared decision-making

 

Meelezers

  • Dr. A. (Adinda) Klijn, spoedeisende hulp arts, NVSHA
  • Drs. C.J. (Christel) de Kuiper, verpleegkundig specialist wondmasters, V&VN
  • Dr. A.T. (Sandra) Bernards, arts-microbioloog, NVMM

 

Met ondersteuning van

  • Drs. M. (Mitchel) Griekspoor, junior adviseur, Kennisinstituut van de Federatie Medisch Specialisten
  • Dr. W.J. (Wouter) Harmsen, adviseur, Kennisinstituut van de Federatie Medisch Specialisten
  • Dr. R. (Romy) Zwarts - van de Putte, adviseur, Kennisinstituut van de Federatie Medisch Specialisten

Belangenverklaringen

De Code ter voorkoming van oneigenlijke beïnvloeding door belangenverstrengeling is gevolgd. Alle werkgroepleden hebben schriftelijk verklaard of zij in de laatste drie jaar directe financiële belangen (betrekking bij een commercieel bedrijf, persoonlijke financiële belangen, onderzoeksfinanciering) of indirecte belangen (persoonlijke relaties, reputatiemanagement) hebben gehad. Gedurende de ontwikkeling of herziening van een module worden wijzigingen in belangen aan de voorzitter doorgegeven. De belangenverklaring wordt opnieuw bevestigd tijdens de commentaarfase.

 

Een overzicht van de belangen van werkgroepleden en het oordeel over het omgaan met eventuele belangen vindt u in onderstaande tabel. De ondertekende belangenverklaringen zijn op te vragen bij het secretariaat van het Kennisinstituut van de Federatie Medisch Specialisten.

 



Werkgroeplid

Functie

Nevenfuncties

Gemelde belangen

Ondernomen actie

Schreve

Vaatchirurg

Niet van toepassing

Geen

Geen

Pierie

Vaatchirurg

Niet van toepassing

Geen

Geen

Westerbos

Orthopeed

Niet van toepassing

Geen

Geen

Loots

Dermatoloog

Niet van toepassing

Geen

Geen

Brölmann

Plastisch chirurg

Niet van toepassing

Geen

Geen

Lenselink

Wondconsulent

Begeleider opleiding wondverpleegkundige, Bestuurslid V&VN, CZO opleidingscommissie, Lid stuurgroep wondopleidingen

Geen

Geen

Reiding

Huisarts

Lid commissie transmurale afspraken wondzorg voor de HOZK

Geen

Geen

Teeven

Spoedeisende hulp arts i.o.,

Niet van toepassing

Geen

Geen

Van Leen

Specialist ouderengeneeskunde

Niet van toepassing

Geen

Geen

Ubbink

Arts en klinisch epidemioloog. Hoogleraar Evidence-based medicine en shared decision-making

Niet van toepassing

Geen

Geen

De Kuiper

Verpleegkundig specialist

Niet van toepassing

Geen

Geen

Bernards

arts-microbioloog

Niet van toepassing

Geen

Geen

Inbreng patiëntenperspectief

Er werd aandacht besteed aan het patiëntenperspectief door het uitnodigen van de Patiëntenfederatie Nederland voor de Invitational conference. De Patiëntenfederatie Nederland is niet op deze uitnodiging ingegaan. De conceptrichtlijn is tevens voor commentaar voorgelegd aan de Patiëntenfederatie Nederland en de eventueel aangeleverde commentaren zijn bekeken en verwerkt.

Methode ontwikkeling

Evidence based

Werkwijze

AGREE

Deze richtlijnmodule is opgesteld conform de eisen vermeld in het rapport Medisch Specialistische Richtlijnen 2.0 van de adviescommissie Richtlijnen van de Raad Kwaliteit. Dit rapport is gebaseerd op het AGREE II instrument (Appraisal of Guidelines for Research & Evaluation II; Brouwers, 2010).

 

Knelpuntenanalyse en uitgangsvragen

Tijdens de voorbereidende fase inventariseerde de werkgroep de knelpunten in de zorg voor patiënten met acute wonden. De werkgroep beoordeelde de aanbeveling(en) uit de eerdere richtlijnmodules (2013) op noodzaak tot revisie. Tevens zijn er knelpunten aangedragen door middel van een digitale Invitational conference. Een verslag hiervan is opgenomen onder aanverwante producten.

 

Op basis van de uitkomsten van de knelpuntenanalyse zijn door de werkgroep concept-uitgangsvragen opgesteld en definitief vastgesteld.

 

Uitkomstmaten

Na het opstellen van de zoekvraag behorende bij de uitgangsvraag inventariseerde de werkgroep welke uitkomstmaten voor de patiënt relevant zijn, waarbij zowel naar gewenste als ongewenste effecten werd gekeken. Hierbij werd een maximum van acht uitkomstmaten gehanteerd. De werkgroep waardeerde deze uitkomstmaten volgens hun relatieve belang bij de besluitvorming rondom aanbevelingen, als cruciaal (kritiek voor de besluitvorming), belangrijk (maar niet cruciaal) en onbelangrijk. Tevens definieerde de werkgroep tenminste voor de cruciale uitkomstmaten welke verschillen zij klinisch (patiënt) relevant vonden.

 

Methode literatuursamenvatting

Een uitgebreide beschrijving van de strategie voor zoeken en selecteren van literatuur en de beoordeling van de risk-of-bias van de individuele studies is te vinden onder ‘Zoeken en selecteren’ onder Onderbouwing. De beoordeling van de kracht van het wetenschappelijke bewijs wordt hieronder toegelicht.

 

 

Beoordelen van de kracht van het wetenschappelijke bewijs

De kracht van het wetenschappelijke bewijs werd bepaald volgens de GRADE-methode. GRADE staat voor ‘Grading Recommendations Assessment, Development and Evaluation’ (zie http://www.gradeworkinggroup.org/). De basisprincipes van de GRADE-methodiek zijn: het benoemen en prioriteren van de klinisch (patiënt) relevante uitkomstmaten, een systematische review per uitkomstmaat, en een beoordeling van de bewijskracht per uitkomstmaat op basis van de acht GRADE-domeinen (domeinen voor downgraden: risk of bias, inconsistentie, indirectheid, imprecisie, en publicatiebias; domeinen voor upgraden: dosis-effect relatie, groot effect, en residuele plausibele confounding).

 

GRADE onderscheidt vier gradaties voor de kwaliteit van het wetenschappelijk bewijs: hoog, redelijk, laag en zeer laag. Deze gradaties verwijzen naar de mate van zekerheid die er bestaat over de literatuurconclusie, in het bijzonder de mate van zekerheid dat de literatuurconclusie de aanbeveling adequaat ondersteunt (Schünemann, 2013; Hultcrantz, 2017).

 

GRADE

Definitie

Hoog

  • er is hoge zekerheid dat het ware effect van behandeling dicht bij het geschatte effect van behandeling ligt;
  • het is zeer onwaarschijnlijk dat de literatuurconclusie klinisch relevant verandert wanneer er resultaten van nieuw grootschalig onderzoek aan de literatuuranalyse worden toegevoegd.

Redelijk

  • er is redelijke zekerheid dat het ware effect van behandeling dicht bij het geschatte effect van behandeling ligt;
  • het is mogelijk dat de conclusie klinisch relevant verandert wanneer er resultaten van nieuw grootschalig onderzoek aan de literatuuranalyse worden toegevoegd.

Laag

  • er is lage zekerheid dat het ware effect van behandeling dicht bij het geschatte effect van behandeling ligt;
  • er is een reële kans dat de conclusie klinisch relevant verandert wanneer er resultaten van nieuw grootschalig onderzoek aan de literatuuranalyse worden toegevoegd.

Zeer laag

  • er is zeer lage zekerheid dat het ware effect van behandeling dicht bij het geschatte effect van behandeling ligt;
  • de literatuurconclusie is zeer onzeker.

 

Bij het beoordelen (graderen) van de kracht van het wetenschappelijk bewijs in richtlijnen volgens de GRADE-methodiek spelen grenzen voor klinische besluitvorming een belangrijke rol (Hultcrantz, 2017). Dit zijn de grenzen die bij overschrijding aanleiding zouden geven tot een aanpassing van de aanbeveling. Om de grenzen voor klinische besluitvorming te bepalen moeten alle relevante uitkomstmaten en overwegingen worden meegewogen. De grenzen voor klinische besluitvorming zijn daarmee niet één op één vergelijkbaar met het minimaal klinisch relevant verschil (Minimal Clinically Important Difference, MCID). Met name in situaties waarin een interventie geen belangrijke nadelen heeft en de kosten relatief laag zijn, kan de grens voor klinische besluitvorming met betrekking tot de effectiviteit van de interventie bij een lagere waarde (dichter bij het nuleffect) liggen dan de MCID (Hultcrantz, 2017).

 

Overwegingen (van bewijs naar aanbeveling)

Om te komen tot een aanbeveling zijn naast (de kwaliteit van) het wetenschappelijke bewijs ook andere aspecten belangrijk en worden meegewogen, zoals aanvullende argumenten uit bijvoorbeeld de biomechanica of fysiologie, waarden en voorkeuren van patiënten, kosten (middelenbeslag), aanvaardbaarheid, haalbaarheid en implementatie. Deze aspecten zijn systematisch vermeld en beoordeeld (gewogen) onder het kopje ‘Overwegingen’ en kunnen (mede) gebaseerd zijn op expert opinion. Hierbij is gebruik gemaakt van een gestructureerd format gebaseerd op het evidence-to-decision framework van de internationale GRADE Working Group (Alonso-Coello, 2016a; Alonso-Coello, 2016b). Dit evidence-to-decision framework is een integraal onderdeel van de GRADE-methodiek.

 

Formuleren van aanbevelingen

De aanbevelingen geven antwoord op de uitgangsvraag en zijn gebaseerd op het beschikbare wetenschappelijke bewijs en de belangrijkste overwegingen, en een weging van de gunstige en ongunstige effecten van de relevante interventies. De kracht van het wetenschappelijk bewijs en het gewicht dat door de werkgroep wordt toegekend aan de overwegingen, bepalen samen de sterkte van de aanbeveling. Conform de GRADE-methodiek sluit een lage bewijskracht van conclusies in de systematische literatuuranalyse een sterke aanbeveling niet a priori uit, en zijn bij een hoge bewijskracht ook zwakke aanbevelingen mogelijk (Agoritsas, 2017; Neumann, 2016). De sterkte van de aanbeveling wordt altijd bepaald door weging van alle relevante argumenten tezamen. De werkgroep heeft bij elke aanbeveling opgenomen hoe zij tot de richting en sterkte van de aanbeveling zijn gekomen.

 

In de GRADE-methodiek wordt onderscheid gemaakt tussen sterke en zwakke (of conditionele) aanbevelingen. De sterkte van een aanbeveling verwijst naar de mate van zekerheid dat de voordelen van de interventie opwegen tegen de nadelen (of vice versa), gezien over het hele spectrum van patiënten waarvoor de aanbeveling is bedoeld. De sterkte van een aanbeveling heeft duidelijke implicaties voor patiënten, behandelaars en beleidsmakers (zie onderstaande tabel). Een aanbeveling is geen dictaat, zelfs een sterke aanbeveling gebaseerd op bewijs van hoge kwaliteit (GRADE gradering HOOG) zal niet altijd van toepassing zijn, onder alle mogelijke omstandigheden en voor elke individuele patiënt.

 

Implicaties van sterke en zwakke aanbevelingen voor verschillende richtlijngebruikers

 

Sterke aanbeveling

Zwakke (conditionele) aanbeveling

Voor patiënten

De meeste patiënten zouden de aanbevolen interventie of aanpak kiezen en slechts een klein aantal niet.

Een aanzienlijk deel van de patiënten zouden de aanbevolen interventie of aanpak kiezen, maar veel patiënten ook niet. 

Voor behandelaars

De meeste patiënten zouden de aanbevolen interventie of aanpak moeten ontvangen.

Er zijn meerdere geschikte interventies of aanpakken. De patiënt moet worden ondersteund bij de keuze voor de interventie of aanpak die het beste aansluit bij zijn of haar waarden en voorkeuren.

Voor beleidsmakers

De aanbevolen interventie of aanpak kan worden gezien als standaardbeleid.

Beleidsbepaling vereist uitvoerige discussie met betrokkenheid van veel stakeholders. Er is een grotere kans op lokale beleidsverschillen. 

 

Commentaar- en autorisatiefase

De conceptrichtlijnmodule werd aan de betrokken (wetenschappelijke) verenigingen en (patiënt) organisaties voorgelegd ter commentaar. De commentaren werden verzameld en besproken met de werkgroep. Naar aanleiding van de commentaren werd de conceptrichtlijnmodule aangepast en definitief vastgesteld door de werkgroep. De definitieve richtlijnmodule werd aan de deelnemende (wetenschappelijke) verenigingen en (patiënt) organisaties voorgelegd voor autorisatie en door hen geautoriseerd dan wel geaccordeerd.

 

Literatuur

Agoritsas T, Merglen A, Heen AF, Kristiansen A, Neumann I, Brito JP, Brignardello-Petersen R, Alexander PE, Rind DM, Vandvik PO, Guyatt GH. UpToDate adherence to GRADE criteria for strong recommendations: an analytical survey. BMJ Open. 2017 Nov 16;7(11):e018593. doi: 10.1136/bmjopen-2017-018593. PubMed PMID: 29150475; PubMed Central PMCID: PMC5701989.

 

Alonso-Coello P, Schünemann HJ, Moberg J, Brignardello-Petersen R, Akl EA, Davoli M, Treweek S, Mustafa RA, Rada G, Rosenbaum S, Morelli A, Guyatt GH, Oxman AD; GRADE Working Group. GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 1: Introduction. BMJ. 2016 Jun 28;353:i2016. doi: 10.1136/bmj.i2016. PubMed PMID: 27353417.

 

Alonso-Coello P, Oxman AD, Moberg J, Brignardello-Petersen R, Akl EA, Davoli M, Treweek S, Mustafa RA, Vandvik PO, Meerpohl J, Guyatt GH, Schünemann HJ; GRADE Working Group. GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 2: Clinical practice guidelines. BMJ. 2016 Jun 30;353:i2089. doi: 10.1136/bmj.i2089. PubMed PMID: 27365494.

 

Brouwers MC, Kho ME, Browman GP, Burgers JS, Cluzeau F, Feder G, Fervers B, Graham ID, Grimshaw J, Hanna SE, Littlejohns P, Makarski J, Zitzelsberger L; AGREE Next Steps Consortium. AGREE II: advancing guideline development, reporting and evaluation in health care. CMAJ. 2010 Dec 14;182(18):E839-42. doi: 10.1503/cmaj.090449. Epub 2010 Jul 5. Review. PubMed PMID: 20603348; PubMed Central PMCID: PMC3001530.

 

Hultcrantz M, Rind D, Akl EA, Treweek S, Mustafa RA, Iorio A, Alper BS, Meerpohl JJ, Murad MH, Ansari MT, Katikireddi SV, Östlund P, Tranæus S, Christensen R, Gartlehner G, Brozek J, Izcovich A, Schünemann H, Guyatt G. The GRADE Working Group clarifies the construct of certainty of evidence. J Clin Epidemiol. 2017 Jul;87:4-13. doi: 10.1016/j.jclinepi.2017.05.006. Epub 2017 May 18. PubMed PMID: 28529184; PubMed Central PMCID: PMC6542664.

 

Medisch Specialistische Richtlijnen 2.0 (2012). Adviescommissie Richtlijnen van de Raad Kwaliteit. http://richtlijnendatabase.nl/over_deze_site/over_richtlijnontwikkeling.html

 

Neumann I, Santesso N, Akl EA, Rind DM, Vandvik PO, Alonso-Coello P, Agoritsas T, Mustafa RA, Alexander PE, Schünemann H, Guyatt GH. A guide for health professionals to interpret and use recommendations in guidelines developed with the GRADE approach. J Clin Epidemiol. 2016 Apr;72:45-55. doi: 10.1016/j.jclinepi.2015.11.017. Epub 2016 Jan 6. Review. PubMed PMID: 26772609.

 

Schünemann H, Brożek J, Guyatt G, et al. GRADE handbook for grading quality of evidence and strength of recommendations. Updated October 2013. The GRADE Working Group, 2013. Available from http://gdt.guidelinedevelopment.org/central_prod/_design/client/handbook/handbook.html.

Zoekverantwoording

Zoekacties zijn opvraagbaar. Neem hiervoor contact op met de Richtlijnendatabase.