Question

When should debridement be carried out to prevent complications and infections?

Recommendation

Carry out initial debridement as quickly as possible following the initial trauma. This should be done by an experienced, trained and well-equipped multidisciplinary team.

 

Debridement should be carried out systematically, working from skin to bone. If necessary, the wound should be lengthened along perforator-sparing fasciotomy lines in order to obtain an adequate overview of the affected area. Further operations should be taken into consideration at this time and discussed in the multidisciplinary team.

 

Irrigate under low pressure with copious amounts of saline solution.

Introduction

Current opinion is that open fractures should initially be debrided within six hours. In the ideal situation this index operation should preferably be done by an experienced multidisciplinary team: a trauma surgeon or orthopaedic trauma surgeon, a plastic surgeon and if there is vascular trauma, a vascular surgeon. These ideal circumstances are not always achievable. Would it be possible to carry out debridement at a later time with the right team, the right operative team with the right expertise available?

Conclusions

Very low GRADE

On the basis of very weak scientific evidence no difference has been shown between the risk of infection associated with early (<6-8 hours) and late debridement (>8 hours) after an open type II or III fracture of the lower limb.

 

Sources (Pollak, 2010; Tripuraneni, 2008; Sungaran, 2007; Reuss, 2007; Kindsfater, 1995; Bednar, 1993)

 

Very low GRADE

On the basis of very weak scientific evidence no difference has been shown between the risk of reoperation associated with early (<6-8 hours) and late debridement (>8 hours) after an open type II or III fracture of the lower limb.

 

Source (Pollak, 2010)

 

No GRADE

No data on the outcomes ADL, return to work or mobility are reported in the literature.

Literature summary

Description of studies

Schenker, 2010 systematically investigated randomised controlled trials (RCTs), quasi-randomised controlled trials and cohort studies containing a minimum of 26 patients over the age of 18 with fractures of the long bones and which contained information on debridement. In order to answer the question, additional inclusion criteria were defined, i.e. open type II or III fractures in the lower limbs. The systematic review included a total of sixteen studies, six of which met the additional criteria requirements. As only parts of the studies have been included, the RCTs are described individually.

 

Pollak, 2010 evaluated the relationship between time to initial treatment of open fractures and the prevention of infection. Patients with a Gustilo Type IIIB, IIIC and a certain type of IIIA open fracture of the tibia, ankle, pilon and foot were included. The patients were between 16 and 69 years-old. They formed part of an existing, larger study (the Lower Extremity Assessment Project [LEAP]). In total, data on time to initial treatment from 307 patients were available. Treatment within five hours of trauma was compared with treatment of between five and ten hours of trauma.

 

Tripuraneni, 2008 looked at the effect of delayed initial treatment on the number of infections in open tibial fractures. A total of 215 tibial fractures in 206 patients with an average age of 39 years were included. Treatment within six hours of admission to the emergency department was defined as early debridement.

 

Sungaran, 2007 determined if a delay in definitive treatment lead to an increase in the number of infections. A total of 161 patients had an open tibial fracture, some also had an open ankle fracture. Early debridement was defined as treatment within six hours of trauma.

 

Reuss, 2007 included 100 successive patients from the age of 18 with 104 open tibial fractures to determine the effect of time to operative debridement and stabilisation of an open tibial fracture on the number of infections and non-union. Treatment within eight hours of admission to ED was compared with treatment given more than eight hours after admission.

 

Kindsfater, 1995 compared the incidence of infection in early and late debridement in type II and III open tibial fractures. A total of 47 tibial fractures in 46 patients with an average age of 34 years were included. Early debridement was defined as treatment within five hours of trauma.

 

Bednar, 1993 studied the effect of treatment delay within 24 hours in 82 open fractures of the femur and tibia in 75 patients. Early debridement was defined as treatment within six hours of trauma.

 

Results

Infections

Pollak, 2010 defined infection as a diagnosis of wound infection or osteomyelitis in the first three months after injury.

 

Tripuraneni, 2008 defined infection as the presence of positive intraoperative tissue or fluid cultures or as clinical proof of purulence requiring reoperation even if intraoperative cultures did not show any growth.

 

Sungaran, 2007 defined infection as the extension or restarting of antibiotic treatment resulting from changes in the wound or changes in the criteria for the further surgical debridement of cellulitis or purulent wounds, chronic infection or osteomyelitis.

 

Reuss, 2007 defined infection as osteomyelitis or deep infection on clinical examination after definitive closure procedures that required operative intervention.

 

Kindsfater, 1995 osteomyelitis was suspected in the presence of fever, erythema, pain/tenderness in the fracture or drainage from the wound. Infections were only classified as such if cultures obtained at operation proved to be positive.

 

Bednar, 1993 defined deep infection as cellulitis, purulent drainage, or a culture positive for osteomyelitis more than six weeks after injury in patients who did not have primary infection.

 

Meta-analysis found a pooled relative risk of 1.19 (95% CI: 0.68 to 2.09; I2=30%) (Figure 1). If only the studies that involving patients with an open tibial fracture are included, the point estimate favours the early carrying out of debridement (RR= 0.86; 95% CI: 0.27 to 2.76; I2=30%). This difference in the direction of the effect is mainly due to Kindsfater’s study, as they alone found an effect in favour of early debridement.

 

Forest plot of early debridement

Figure 1 Forest plot of early debridement (between 0-8 hours) compared with late debridement (after 6-8 hours) and the risk of infection in patients with a type II or II open fracture of the lower limb.

 

Readmission or reoperation

Only Pollak, 2010 looked at the risk of severe infection which they defined as an infection resulting in readmission. They found that there was no difference in the risk of reoperation between early and late debridement (OR = 0.88; 95% CI 0.45 to 1.72).

 

ADL, returning to work and mobility

None of the studies looked at these outcomes.

 

Strength of evidence of the literature

The strength of evidence started low as the results were obtained from observational study. The strength of evidence for the outcomes infection and readmission was lowered by one level from low to very low due to limitations in the design of the study (no correction for confounding) and the small number of infections (imprecision).

Search and select

In order to answer this clinical question a systematic literature analysis was carried out in order to answer the following research question:

What are the beneficial/unfavourable effects of carrying out debridement within six hours versus later than six hours in patients with a grade III open fracture of the lower limb?

 

P: Patients with a grade III open fracture of the lower limb

I: Debridement within six hours

C: Debridement later than six hours

O: Osteitis, osteomyelitis, number of readmissions, number of reoperations, function (ADL), pain (VAS), complications, return to work, mobility (distance walked, speed of walking).

 

Relevant outcome measures

With the exception of the risk of infection, the working party did not define the outcome measures in advance, but adopted the definitions used in the studies. A difference of 5% was chosen as a clinically relevant difference.

 

Method of searching and selection

The clinical question was based on the systematic review of Schenker et al. (2012). This review looked at the association between operative debridement of open fractures and infections and searched up to December 2010. For purposes of the clinical question, it was decided to update this review.

 

The databases Medline (OVID) and Embase were searched for relevant search terms and (randomised) controlled studies. The search strategy is shown under the tab Methods. The literature search gave 28 hits. Studies were selected on the grounds of the following selection criteria as defined in the review (>25 study participants, aged 18 and over, clinical and radiographic data on the fracture at the start of the study and during follow-up, and data on the outcome measures wound healing, infections investigated in a prospective study design. One study was initially selected on the basis of title and abstract. After reading the complete text, this study was excluded (see exclusion table) and no additional studies, apart from the review, were selected. The review included studies of patients with an open femoral/tibial and/or humeral fracture level I-II or III. Only those studies in which patients with an open tibial fracture level II or III were investigated were included in the literature analysis for this clinical question.

 

 (Results)

Schenker’s systematic review included sixteen studies in the literature analysis. Six of these met the additional inclusion criteria for this clinical question. The evidence tables and assessment of individual study quality can be found under the tab Evidence Base.

References

  1. Bednar DA, Parikh J. Effect of time delay from injury to primary management on the incidence of deep infection after open fractures of the lower extremities caused by blunt trauma in adults. J Orthop Trauma. 1993;7:532-5.
  2. FLOW Investigators, Bhandari M, Jeray KJ, et al. A Trial of Wound Irrigation in the Initial Management of Open Fracture Wounds. N Engl J Med. 2015 31;373(27):2629-41.
  3. Kindsfater K, Jonassen EA. Osteomyelitis in grade II and III open tibia fractures with late debridement. J Orthop Trauma. 1995;9:121-7.
  4. Pollak AN, Jones AL, Castillo RC, et al. The relationship between time to surgical debridement and incidence of infection after open high-energy lower extremity trauma. J Bone Joint Surg Am. 2010;92:7-15.
  5. Reuss BL, Cole JD. Effect of delayed treatment on open tibial shaft fractures. Am J Orthop (Belle Mead NJ). 2007;36:215-20.
  6. Sungaran J, Harris I, MouradM. The effect of time to theatre on infection rate for open tibia fractures. ANZ J Surg. 2007;77:886-8.
  7. Schenker ML, Yannascoli S, Baldwin KD, et al. Does timing to operative debridement affect infectious complications in open long-bone fractures? A systematic review. J Bone Joint Surg Am. 2012 20;94(12):1057-64.
  8. Tripuraneni K, Ganga S, Quinn R, Gehlert R. The effect of time delay to surgical debridement of open tibia shaft fractures on infection rate. Orthopedics. 2008;31.

Evidence tables

Study reference

Study characteristics

Patient characteristics

Intervention (I)

Comparison / control (C)

Follow-up

Outcome measures and effect size

Comments

Schenker,

2012

 

[individual study characteristics deduced from Schenker,

2012]

 

PS., study characteristics and results are extracted from the SR (unless stated otherwise)

SR and meta-analysis of RCTs, quasi-randomized controlled trials, cohort studies

 

Literature search up to December 2010

 

A: Pollak, 2010

B: Tripuraneni, 2008

C: Sungaran, 2007

D: Reuss, 2007

E: Kindsfater, 1995

F: Bednar, 1993

 

Study design:

A: Cohort (prospective)

B: Cohort (retrospective)

C: Cohort (retrospective)

D: Cohort (retrospective)

E: Cohort (retrospective)

F: Cohort (retrospective)

 

Setting and Country:

A: Level-I trauma center, USA

B: Level-I trauma center, USA

C: Tertiary referral trauma centre, Australia

D: Level-I trauma center, USA

E: Hospital, USA

F: University hospital and trauma referral center, Canada

 

Source of funding:

A: Non-commercial

B: Unknown

C: Unknown

D: None

E: Unknown

F: Unknown

 

Inclusion criteria SR:

  • · Minimum of 26 subjects
  • · Data for patients >18 yrs
  • · Clinical and radiographic evidence of fracture union at follow-up
  • · Evidence of completeness of wound healing
  • · Infectious outcomes
  • · Open long-bone fractures with time to debridement as a metric
  • · Level I, II or III therapeutic of prognostic study design

 

Exclusion criteria SR:

  • · Not performed in human subjects
  • · Did not allow outcomes of open fractures to be distinguished from outcomes of closed fractures
  • · Classified gunshot wounds as open fractures
  • · Did not involve long bones

 

16 studies included; additional inclusion criteria were: open fractures in the leg of type II or III. A total of six studies were included and described.

 

Important patient characteristics at baseline:

 

N, mean age

A: 307 patients, range 16-69 yrs

B: 215 fractures in 206 patients, mean 39 yrs

C: 161 patients; Not reported

D: 81 fractures in 77 patients; >17 yrs

E: 47 fractures in 46 patients; mean 34 yrs (range 8-71)

F: 91 fractures in 84 patients; mean 34 yrs (range 16-63)

 

% Male:

A: Not reported

B: Not reported

C: Not reported

D: 63 (78)

E: 37 (79)

F: 72 ((96)

 

Groups comparable at baseline?

 

A: Not reported

B: Not reported

C: Not reported

D: Not reported

E: Not reported

F: Not reported

Early debridement between:

A: 0-5 hrs

B: 0-6 hrs

C: 0-6 hrs

D: <8 hrs

E: 0-5 hrs

F: 0-6 hrs

 

Late debridement between:

 

A: 5 – >10 hrs

B: 6 – >24 hrs

C: 6 – 24 hrs

D: >8 hrs

E: >5 hrs

F: 7-24 hrs

 

End-point of follow-up:

 

A: Minimum of 3 months after injury

B: Mean 10 months (range 2 weeks to 52 months)

C: Not reported

D: Mean 14 months (range 5 weeks to 61 months)

E: Mean 19 months (range 6 to 48 months)

F: Mean 18 months (range 6 to 38 months)

 

For how many participants were no complete outcome data available?

(intervention/control)

A: Unknown

B: Unknown

C: Unknown

D: Unknown

E: Unknown

F: 0 (0%)

 

 

 

Comparison: Early vs late

 

Outcome measure-1

Defined as infection

 

I: n/N; C: n/N

Effect measure: RR [95% CI]

A (within 3 months after injury):

I: 26/93; C: 58/214

Unadjusted OR:

1.04 (0.61-1.80)

B:

I: 6/43; C: 10/110

Unadjusted OR:

1.62 (0.55-4.77)

C:

I: 5/58; C: 1/75

Unadjusted OR:

6.98 (0.79-61.50)

D:

I: 3/26; C: 4/41

Unadjusted OR:

1.21 (0.25-5.89)

E:

I: 1/15; C: 12/32

Unadjusted OR:

0.12 (0.01-1.02)

F: (more than 6 weeks after injury):

I: 2/20; C: 2/43

Unadjusted OR:

2.28 (0.30-17.46)

 

Pooled effect (random effects model model) early vs late debridement:

OR 1.23 [95% CI 0.62 to 2.46]

Heterogeneity: p=0.162

 

Outcome measure-2

Defined as rehospitalisation or -surgery

 

I: n/N; C: n/N

Effect measure: RR [95% CI]

A: Measured as major infections resulting in rehospitalisation

I: 14/93; C: 36/214

Unadjusted OR:

0.88 (0.45-1.72)

 

Outcome measure-3

Defined as ADL, return to work or mobility

 

None of the studies reported data on this outcome.

 

Outcome measure-4

Defined as complications or pain

 

None of the studies reported data on this outcome.

 

 

 

 

 

 

Authors’ conclusion: The data did not indicate an association between delayed debridement and higher infection rates when all infections were considered, or when only more severe open fracture injuries were considered.

 

Level of evidence: GRADE

Outcome measure 1: Infection

VERY LOW

 

Outcome measure 2: Rehospitalisation or -surgery

VERY LOW

 

The level of evidence was downgraded from LOW to VERY low, because of no adjustment for confounders (Risk of Bias) and small number of infection in studies (Imprecision).

 

Comment:

E: Study undertook analyse per 1 hour blocks to check the time delay from injury until debridement and the risk of infections

 

Subgroup analysis

0-6 hrs vs >6hrs

 

Not possible

 

Risk of bias table for intervention studies (observational: non-randomized clinical trials, cohort and case-control studies)

Study reference

 

 

 

(first author, year of publication)

Bias due to a non-representative or ill-defined sample of patients?1

 

 

 

(unlikely/likely/unclear)

Bias due to insufficiently long, or incomplete follow-up, or differences in follow-up between treatment groups?2

 

(unlikely/likely/unclear)

Bias due to ill-defined or inadequately measured outcome ?3

 

 

 

(unlikely/likely/unclear)

Bias due to inadequate adjustment for all important prognostic factors?4

 

 

 

(unlikely/likely/unclear)

Pollak, 2010

Unlikely

Unclear

Unlikely

Likely

Tripuraneni, 2008

Unlikely

Unlikely

Unlikely

Likely

Sungaran, 2007

Unlikely

Unclear

Unlikely

Likely

Reuss, 2007

Unclear

Unlikely

Unlikely

Likely

Kindsfater, 1995

Unlikely

Unlikely

Unlikely

Likely

Bednar, 1993

Unlikely

Unlikely

Unlikely

Likely

 

Table Excluded after reading complete article

Author and year

Reason for exclusion

Weber, 2014

Analysis of all long bones

Considerations

In 1898 Friedrich showed that guinea pigs with an open fracture stayed healthy if the fracture was debrided with six hours. This was the start of the ‘six-hour rule’ which is applied to the debriding or closure of open wounds. The assumption is that the risk of infection is smallest at this time. There are cases where it is not possible to start treatment within six hours. Systematic literature analysis shows that there is only very weak evidence for optimal timing. What literature there is does not show any clear advantage of either early or late debridement, but this evidence is too weak to be able to state that the timing of debridement makes no difference. Additionally, the contrast between early and late debridement is very small, even with an overlap of 6-8 hours.

 

The value of initial debridement has been underestimated; this should be meticulously carried out and all devitalised tissue must be excised. Less than complete debridement carries the risk of developing infection. Debridement should be carried out systematically from skin to bone. The vitality and blood supply to each layer of tissue should be assessed and then tissues excised accordingly. If necessary, a traumatic wound should be lengthened along the fasciotomy lines in order to obtain an overview of the whole affected area. To prevent further iatrogenic damage to traumatised tissue, it is sometimes sensible to do the exploration through the incision planned for osteosynthesis. All contaminated and necrotic tissue must be excised until only well-perfused tissue remains. An exception to this is the skin from which only obviously necrotic tissue should be removed. The vitality of muscle tissue can be assessed by doing the four C’s test: colour (red or brown?), consistency (how does the tissue feel?), capillary circulation (is it bleeding?), contractility (response to forceps/diathermy). Fracture ends can be assessed by delivering them through the wound. Fracture ends should be cleaned by curettage so that all necrotic and contaminated bone is removed. Fragments of bone that are not attached to tissue should be removed. Exceptions to this are larger joint fragments. These should be spared if they can be reduced and fixed with absolute stability. Finally, the wound should be irrigated with copious quantities of saline solution; 6-9 litres in grade III fractures (Anglen, 2001). This is best delivered at low pressure, for example by hanging the bag of saline from a drip stand.

 

A multidisciplinary approach from an experienced team appears to be indispensable and the six-hour rule is perhaps less important. Of course, there are indications for rapid surgical intervention. Heavy contamination, acute compartment syndrome, an avascular limb and polytrauma are absolute indications for urgent intervention. The working party is of the opinion that treatment must be carried out within twelve hours in every case.

 

Taking this into consideration together with the existing literature which is graded as very low, it seems logical that initial debridement should be carried out within the shortest possible time by a complete and experienced multidisciplinary team (for composition of team see module on organisation of care). Exactly what the shortest possible time should be is controversial. Logically, it takes time to mobilise a complete multidisciplinary team and this can take more than six hours.

 

The way hospitals are currently organised means that this regularly takes place at night when not all the team are present. If the team is not available, and if the contamination and other injuries permit it, it is preferable to organise care in such a way that these patients are first on the operating list in the morning. If the correct team makes the assessment, then the preferred type of fixation can also be decided upon at that time. Furthermore, should internal fixation be chosen as the definitive procedure then the external fixator phase can be omitted.

Authorization date and validity

Last review : 01-01-2017

Last authorization : 01-01-2017

The executive board of the NVvH will assess these guidelines no later than 2020 to determine if they are still valid. If necessary, a new working party will be set up to review the guidelines. If there are new developments, the validity of the guidelines will expire earlier and a review will take place. The working party does not deem it necessary to separately specify validity at a modular level.

 

As owners of these guidelines, the primary responsibility to keep them up-to-date rests with the NVvH. Other participating professional bodies or users of the guidelines share the responsibility and are required to inform the NVvH about relevant developments in their fields.

Initiative and authorization

Initiative : Nederlandse Vereniging voor Heelkunde

Authorized by:
  • Nederlandse Orthopaedische Vereniging
  • Nederlandse Vereniging van Revalidatieartsen
  • Nederlandse Vereniging voor Plastische Chirurgie

General details

The development of these guidelines was financed by the Quality Foundation of the Dutch Medical Specialists (SKMS).

Scope and target group

What is the aim (desired effect) of the guidelines?

The recognition and acknowledgement of the complexity of a fracture of the lower limb with significant soft tissue injury is of the greatest of importance in developing an appropriate multidisciplinary treatment strategy. The specialisations involved must be very aware of their own abilities and limitations, and on the basis of these must work in partnership right from when the patient is first presented. Standardisation of therapeutic options by means of a treatment algorithm is necessary. The development of multidisciplinary, evidence-based guidelines contributes to this.

 

Currently, the treatment of an open lower limb fracture is not managed by a scientifically supported and multidisciplinary policy, but more likely by the local traditions of the hospital at which the patient presents. This often causes confusion about the most appropriate method of primary fixation, the timing and the extent of aggressiveness of the debridement and the planning for definitive coverage of the soft tissues.

 

In the Netherlands, there is currently no standardised treatment for patients with an open fracture of the lower limb. There are British guidelines on this injury (BAPRAS/BOA, 2009), but these are not always applicable to the Dutch situation for a number of reasons, including the differing ways in which care is organised. National, evidence-based guidelines are of considerable importance in supporting health care professionals in their clinical decision-making and in providing transparency to patients and third parties. It covers topics in several areas including the early and late treatment of open fractures of the lower limb, the timing and kind of  surgical debridement, bone stabilisation, soft tissue cover and rehabilitation. The ultimate goal is to create a primary multidisciplinary treatment pathway whereby patients with complex open fractures of the lower limb can be treated quickly and to a high standard.

 

Defining the guidelines

The guidelines are aimed at all patients with an open fracture of the lower limb, and in particular at those patients with a grade III (a, b or c) open injury in accordance with the classification of Gustilo and Anderson. The principles of treatment described in these guidelines are also applicable to open fractures in other parts of the skeleton, such as the ankle.

 

Envisaged users of the guidelines

These guidelines have been written for all members of those professional groups who are involved in the medical care of adults or children with an open fracture of the lower limb: emergency department physicians, trauma surgeons, orthopaedic surgeons, plastic surgeons, rehabilitation physicians, physiotherapists, nurses and wound consultants.

Members of the guideline panel

In 2014, a multidisciplinary working party was set up to develop these guidelines. It comprised representatives from all those relevant specialisations involved in the care of patients with a grade III open fracture of the lower limb (see below).

 

The members of the working party were mandated for participation by their professional organisation. The working party worked for two years to develop these guidelines.

 

The working party is responsible for the integral text of these guidelines.

  • Dr M.J. Elzinga, trauma surgeon (NVvH), Haga Hospital, The Hague (Chair)
  • Dr J.M. Hoogendoorn, trauma surgeon (NVvH), Medical Centre Haaglanden-Bronovo, The Hague, The Netherlands.
  • Dr P. van der Zwaal, orthopaedic surgeon (NOV), Medical Centre Haaglanden-Bronovo, The Hague, The Netherlands.
  • Dr D.J. Hofstee, orthopaedic surgeon (NOV), Noordwest Hospital Group, The Netherlands
  • J.G. Klijnsma, physiotherapist (KNGF), University Medical Centre Utrecht, The Netherlands
  • Dr P. Plantinga, emergency department physician (NVSHA), Rijnstate Hospital, Arnhem, The Netherlands.
  • Dr H.R. Holtslag, rehabilitation physician (VRA), Academic Medical Centre, Amsterdam, The Netherlands.
  • Dr E.T. Walbeehm, plastic surgeon (NVPC), Radboud Hospital, Nijmegen, The Netherlands.
  • Dr H.A. Rakhorst, plastic surgeon (NVPC), Medisch Spectrum, Twente, The Netherlands.

 

With the help of:

  • Dr W.A. van Enst, senior advisor, Knowledge Institute of Medical Specialists

 

With thanks to:

  • Dr C.W. Ang, medical microbiologist, VU Medical Centre, Amsterdam. The Netherlands.

Declaration of interest

The members of the working party have declared in writing if, in the last five years, they have held a financially supported position with commercial businesses, organisations or institutions that may have a connection with the subject of the guidelines. Enquiries have also been made into personal financial interests, interests pertaining to personal relationships, interests pertaining to reputation management, interests pertaining to externally financed research, and interests pertaining to valorisation of knowledge. These Declarations of Interest can be requested from the secretariat of the Knowledge Institute of Medical Specialists. See below for an overview.

 

Name of member of  working party

Interests: Yes/No

Remarks

M.J. Elzinga

No

 

Dr J.M. Hoogendoorn

No

 

Dr P. van der Zwaal

Yes

Member of an Orthopaedic & Traumatology partnership financially supported by Biomet in the interests of scientific research

Dr D.J. Hofstee

No

 

Mr J.G. Klijnsma

No

 

P. Plantinga

No

 

Dr H.R. Holtslag

No

 

Dr E.T. Walbeehm

No

 

Dr H.A. Rakhorst

No

 

Patient involvement

The perspective of the patient was included by organising a focus group. This report can be found in the appendices. The concept guidelines was presented to the Patient Federation NPCF for their comments.

Method of development

Evidence based

Implementation

Introduction

This plan has been drawn up with the aim of advancing the implementation of these guidelines. In order to compile this plan, an inventory of factors that could either facilitate or hinder the recommendations was carried out.  The guideline working group has made recommendations concerning the timeline for implementation, the preconditions necessary for this and the actions that should be taken by various parties.

 

Methodology

In order to arrive at this plan, the working party has applied the following to each recommendation in the guidelines:

  • the time point by which the recommendations should have been nationally implemented;
  • the expected impact of implementation of the recommendation on healthcare costs; preconditions necessary to be able to implement the recommendation; possible barriers to the implementation of the recommendation; possible actions to advance the implementation of the recommendation; the party responsible for the actions to be undertaken.

Readers of this implementation plan should take the differences between ‘strong’ recommedations and ‘weak’ recommendations into account. In the former case, the guideline committee clearly states what should or should not be done. In the latter case, the recommendation is less strong and the working party expresses a preference but leaves more room for alternatives. One reason for this could be that there is insufficient research evidence to support the recommendation. A weak recommendation can be recognised by its formulation and may begin with something like ‘Consider the…’. The working party has considered the implementation of both weak and strong recommendations. A time frame for implementation is only indicated for strong recommendations.

 

Time frames for implementation

Strong recommendations should be followed as strictly as possible. In most cases, this will mean that the recommedations should be implemented within one year of the publication of the guidelines.

However, some recommedations will not be directly implemented everywhere. This could be due to a lack of facilities, expertise or correct organisational structure. In some cases, account should be taken of the learning curve. In addition, the unavailability of staff or facilities or lack of agreement between professionals may hinder the implementation  in the short term.

 

It is for these reasons that the following recommendations are based on estimates made by the guideline working group, and an implementation period of between one and three years should be allowed for:

Recommendation

Remarks

At the scene, treat patients with an open fracture of the lower limb in accordance with the Netherlands National Protocol of Ambulance Care (LPA) and Prehospital Trauma Life Support (PHTLS) principles.

  • Align and straighten dislocated fractures as much as possible;
  • Cover open wounds with sterile gauze dressings soaked in a saline solution and apply a pressure bandage;
  • Apply a splint before transport.

Taking note of the guidelines is sufficient for implementation

Take photographs of the injuries so the temporary dressing does not continually need to be disturbed (important for the privacy of the patient).

Taking note of the guidelines is sufficient for implementation

Assess the wound, vascular status and nerve injury and classify the injury in accordance with the Gustilo and Andersen classification.

Taking note of the guidelines is sufficient for implementation

Assess and describe the degree of contamination and the extent of the soft tissue injuries.

Taking note of the guidelines is sufficient for implementation

Repeat neurovascular status assessment paying special attention to the development of compartment syndrome and acute vascular threat to the leg.

Taking note of the guidelines is sufficient for implementation

Avoid taking wound cultures in the ED.

Taking note of the guidelines is sufficient for implementation

Take plain radiographs in two directions (AP and lateral) including the proximal and distal joints.

Taking note of the guidelines is sufficient for implementation

If peripheral pulsations are intact, then only carry out CT angiography on indication (clinical suspicion or preoperative work-up).

Taking note of the guidelines is sufficient for implementation

If the leg is acutely threatened surgical exploration and shunting be should carried out in order to keep acute ischaemic time to a minimum. The site of the vascular damage can be accurately determined using conventional radiological diagnostics and the level of the area of trauma.

Taking note of the guidelines is sufficient for implementation

In ED remove those contaminants that are easy to remove, and leave perforating objects (e.g. cables or slivers of metal or glass) in situ.

Taking note of the guidelines is sufficient for implementation

Wound irrigation should emphatically not take place in the ED.

Taking note of the guidelines is sufficient for implementation

Cover wounds with sterile gauze soaked in a saline solution.

Taking note of the guidelines is sufficient for implementation

Align dislocated fractures and apply a splint.

Taking note of the guidelines is sufficient for implementation

Intravenous antibiotics and a tetanus vaccination should be administered as early as possible in accordance with regional protocol.

Taking note of the guidelines is sufficient for implementation

Pain relief should be started as quickly as possible and in accordance with local protocol or guidelines on trauma patients in the emergency care pathway.

Taking note of the guidelines is sufficient for implementation

Debridement should be carried out systematically, working from skin to bone. If necessary, the wound should be lengthened along perforator-sparing fasciotomy lines in order to obtain a good overview of the affected area. Any further operations should be taken into consideration at this time and this should be discussed by the multidisciplinary team.

Staff training, specifically aimed at the treatment of open fractures of the lower limb

Irrigate under low pressure using plenty of saline solution.

Staff training, specifically aimed at the treatment of open fractures of the lower limb

Negative pressure therapy is the treatment of preference as a temporary wound cover as it helps to prevent infections and aids patient comfort.

Staff training, specifically aimed at the treatment of open fractures of the lower limb

If negative pressure therapy is not technically possible, the second choice is saline-soaked gauze dressings which have then been wrung out.

Staff training, specifically aimed at the treatment of open fractures of the lower limb

The application of a temporary wound cover should not deter the early and definitive covering of soft tissues.  

Dependent on the availability of enough adequately trained staff or on care arrangements with other hospitals.

Aim to achieve primary internal fixation with nail or plate if good soft tissue cover is possible and the leg can be reasonably expected to bear weight.

  • Apply a spanning external fixator if definitive fixation and immediate soft tissue cover are not carried out at the time of initial debridement.
  • Replace the external fixator with internal fixation as quickly as possible.
  • Open lower limb fractures of the shaft should preferably be fixed with a reamed intramedullary nail.
  • Fix open distal/proximal metaphyseal lower limb fractures with a fixed angle plate or with an intramedullary nail.

 

Staff training, specifically aimed at the treatment of open fractures of the lower limb

The working party neither recommends nor discourages primary bone grafting in open fractures.

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As little research has been done in the area of primary bone grafting, for the time being this technique should be used in a study setting.

Registration and permission from ethics committee to collect and study patient data should be organised.

Definitive reconstruction of the soft tissues in open fracture of the lower limb should take place as quickly as possible, within a maximum of one week, if the condition of the patient permits this.

Dependent on the availability of enough adequately trained staff or on care arrangements with other hospitals. Staff training, specifically aimed at the treatment of open fractures of the lower limb

Keep as much length and tissue as possible and, where feasible, repair soft tissue injury with skin grafts.

Taking note of the guidelines is sufficient for implementation Supplemented by further training

Involve a rehabilitation physician as quickly as possible following the accident; preferably preoperatively to advise the patient.

Taking note of the guidelines is sufficient for implementation

If a transtibial amputation is not possible, carry out disarticulation of the knee in preference to transfemoral amputation.

Taking note of the guidelines is sufficient for implementation

When treating grade III open fractures, an antibiotic such as cefazolin which protects against Staphylococcus aureus should be given.

Taking note of the guidelines is sufficient for implementation

In grade III open fractures, antibiotics should be given until the soft tissues have been closed, preferably a maximum of 72 hours.

Taking note of the guidelines is sufficient for implementation

Consult a microbiologist on antibiotic therapy in the event of exceptional contaminants (marine, animal housing or sewerage). In grade III fractures consider adding an extra drug (e.g. an aminoglycoside such as tbramycin, gentamycin or ciprofloxacin), or using a third-generation cephalosporin (a potential disadvantage of these drugs being they are less effective against S aureus).

Taking note of the guidelines is sufficient for implementation

Consult a microbiologist on antibiotic therapy in the event of exceptional contaminants (marine, animal housing or sewerage).

Taking note of the guidelines is sufficient for implementation

Start exercise therapy as quickly as possible postoperatively.

Taking note of the guidelines is sufficient for implementation

Exercise therapy should be primarily aimed at disorders of function as specified in the ICF model (function of leg musculature, ROM of knee and ankle), and secondarily at activities (standing and walking).

Taking note of the guidelines is sufficient for implementation

In consultation with patient and surgeon set treatment targets for exercise therapy while taking the weight-bearing capacity of bone and soft tissues into consideration.

Taking note of the guidelines is sufficient for implementation

Over time, adapt these exercise therapy targets to the biological and mechanical possibilities and limitations of the wound, bone and soft tissues, the surgical procedure and potential complications.

Taking note of the guidelines is sufficient for implementation

Should quantification of physical functioning be called for, six-weekly WOMAC and SF-36 are recommended.

Taking note of the guidelines is sufficient for implementation

Return to work and quality of life are determined by personal and environmental factors.

Taking note of the guidelines is sufficient for implementation

If necessary, take measures to prevent talipes equinus.

Taking note of the guidelines is sufficient for implementation

Nominate a primary treating physician.

Taking note of the guidelines is sufficient for implementation

Make local or regional arrangements regarding the organisation of care for patients with a grade III open fracture of the lower limb and register this in a protocol.

Taking note of the guidelines is sufficient for implementation

Arrange to discuss the definitive treatment plan with the patient and family or close friends. Point out the possible treatment options, the risks associated with these options, and the expected results.

Taking note of the guidelines is sufficient for implementation

The meeting should be led by, or be held in the presence of, the primary treating physician.

Taking note of the guidelines is sufficient for implementation

 

The following recommendations are based on estimates made by the guideline committee, and an implementation period of between three to five years should be allowed for:

 

Recommendation

Remarks

The initial debridement should be done as quickly as possible, certainly within twelve hours of the initial trauma. It should be carried out by an experienced, trained and well-equipped multidisciplinary team.

Hospitals should have enough staff available to be able to provide a multidisciplinary team, or they should have arrangements with other institutions who are able to provide care from a multidisciplinary team.

The decision to continue temporary wound dressings for longer than one week is one that should be made by the primary multidisciplinary team.

Hospitals should have enough staff available to be able to provide a multidisciplinary team, or they should have arrangements with other institutions who are able to provide care from a multidisciplinary team.

Form a multidisciplinary team comprising a minimum of trauma surgeon/orthopaedic surgeon, a plastic surgeon and a rehabilitation physician.

Hospitals should have enough staff available to be able to provide a multidisciplinary team, or they should have arrangements with other institutions who are able to provide care from a multidisciplinary team.

The multidisciplinary team should see the patient preoperatively (rehabilitation physician if indicated) and together draw up a treatment plan.

Hospitals should have enough staff available to be able to provide a multidisciplinary team, or they should have arrangements with other institutions who are able to provide care from a multidisciplinary team.

 

Impact on healthcare costs

Many of these recommendations will have few or no consequences for the cost of healthcare. However, the deployment of a multidisciplinary team will possibly increase direct costs. Conversely, if the guidelines are adhered to the number of infections and reoperations will be reduced thus reducing costs. The savings are larger than the cost of the multidisciplinary team. Other recommendations do not affect costs, or may even save them. 

 

Actions to be undertaken by each party

Below is a list of actions that in the opinion of the guideline working group should be undertaken to facilitate the implementation of the guidelines.

 

All academic and professional organisations that are directly involved (NVvH, NVPC, NOV, VRA, KNGF).

  • Tell members about the guidelines. Publicise the guidelines by writing about them in journals and disseminating news of them at congresses.
  • Provide professional education and training to ensure that the expertise required to follow the guidelines is available.
  • Where relevant and possible, develop resources, instruments and/or digital tools to facilitate the implementation of the guidelines.
  • Monitor the way in which the recommendations are put into practice by means of audits and quality inspections.
  • Include indicators developed for these guidelines in quality registrations and indicator sets.
  • Make interprofessional agreements about implementing continuous modular maintenance of the guidelines.

 

Initiatives to be undertaken by the professional organisation NVvH

  • Hospital management boards and other system stakeholders (where applicable), should be kept informed of recommedations that could have an effect on the organisation of care and on costs, and on what may be expected by the party concerned.
  • Publicise the guidelines to other interested academic and professional bodies.

 

Local professional groups / individual medical professionals

  • Discuss the recommendations at meetings of professional groups and local working parties.
  • Tailor local protocols to fit the recommendations from the guidelines.
  • Follow the continuing professional education on these guidelines (yet to be developed). 
  • Modify local information for patients using the materials that the professional bodies will make available. 
  • Make agreements with other disciplines involved to ensure the implementation of the recommedations in practice.
  • Register pre- and postoperative factors and, as far as is possible, include important considerations for decision-making in existing protocols and the electronic dossier.

 

The system stakeholders (including health insurers, NZA, hospital managers and their associations, IGZ)

In relation to the financing of care for patients with open fracture of the lower limb, it is expected that hospital management boards will be prepared to make the investments necessary to enable the implementation of these guidelines (see impact on healthcare costs above). In addition, hospital managers are expected to monitor those medical professionals concerned and ascertain how familiar they are with the new guidelines and how they are putting them into practice.

Health insurers are expected to reimburse the costs of the care that is prescribed in these guidelines. When the time frames for implementation have elapsed, health insurers can use the strong recommendations in these guidelines for purposes of purchasing care.

 

Researchers and subsidy providers

Initiate research into the knowledge gaps, preferably in a European setting.

 

Knowledge Institute of Medical Specialists

Publicise these guidelines among the staff and contect to development of related guidelines, e.g. on ankle fractures and post-osteosynthesis infection.

Add guidelines to guideline database. Incorporate this implementation plan in a place where all parties will be able to find it.

Methods and proces

AGREE II

These guidelines were developed in accordance with the publication Medical Specialists Guidelines  2.0 report from the advisory committee on Guidelines from the Committee on Quality. This report is based on the AGREE II instrument (Appraisal of Guidelines for Research & Evaluation II) (http://www.agreetrust.org/agree-ii/). This is a widely-accepted internationally used instrument and is based on  ‘Guideline to guideline for the assessment of quality of guidelines (http://www.zorginstituutnederland.nl/).

 

Inventory of problem areas

During the preparation stage, the Chair of the Working Party and the Advisor made an inventory of problem areas. The Dutch health insurance companies were invited to contribute their problem areas to the guidelines.

 

Clinical questions and outcome measures

Based on the outcomes of the problem area analysis, the Chair and the Advisor compiled concept clinical questions. These were discussed with the working party, after which time the working party approved the definitive clinical questions. The working party then decided which outcome measures of each of the clinical questions are relevant to the patient, and both desirable and undesirable effects were examined. The working party then rated these outcome measures and categorised their relative importance as crucial, important or unimportant. In as far as was possible, the working party also defined what they found to be clinically relevant difference in the outcome measures, i.e. if the improvement in outcome was an improvement for the patient.

 

Strategy for searching and selecting the literature

For purposes of orientation, we looked for existing guidelines from outside the Netherlands (Guidelines International Network, Trip and National guideline clearing house (USA) European and American professional organisations), and systematic reviews (Medline, Embase, Cochrane Database of Systematic Reviews). Then, using specific search terms from the individual clinical questions, the working party searched for published studies in various electronic databases. Studies from the reference lists of the selected articles were also included in the search. Initially, studies with the highest level of evidence were searched for. The members of working party then went through the articles found in the search and selected articles based on predetermined selection criteria. The selected articles were used to answer the clinical questions. The databases searched, the search action or key words of the search action and the selection criteria used are defined in the search strategy of the clinical question concerned.

 

Quality evaluation of individual studies

In order to estimate the risk of bias in the study results, individual studies were systematically evaluated on the basis of previously determined methodological quality criteria. These evaluations can be found in the methodological checklists.

 

Summary of the literature

The relevant data from all studies included are shown in evidence tables. The most important findings from the literature were described in the summary of the literature. In the event of enough agreement between studies, the data were summarised quantitatively in a meta-analysis. This was done with Review Manager software from the Cochrane Collaboration.

 

Evaluation of the strength of scientific evidence

A) Intervention and diagnostic questions

Evaluation of the strength of scientific evidence was determined in accordance with the GRADE method. GRADE stands for  ‘Grading Recommendations Assessment, Development and Evaluation’ (see http://www.gradeworkinggroup.org/) (Atkins, 2004).

 

GRADE distinguishes four grades of quality of evidence, i.e. high, moderate, low and very low. These grades indicate the degree of confidence in the conclusions in the literature (see http://www.guidelinedevelopment.org/handbook/). 

 

GRADE

Definition

High

  • There is a high degree of confidence that the true effect of treatment is very close to the estimated effect of treatment as reported in the conclusion in the literature.
  • It is very unlikely that the conclusion drawn in the literature will change if further research is done.

Moderate

  • There is a moderate degree of confidence that the true effect of treatment is very close to the estimated effect of treatment as reported in the conclusion in the literature.
  • It is possible that the conclusion drawn in the literature will change if further research is done.

Low

  • There is a limited degree of confidence that the true effect of treatment is very close to the estimated effect of treatment as reported in the conclusion in the literature.
  • It is probable that the conclusion drawn in the literature will change if further research is done.

Very low

  • There is little confidence that the true effect of treatment is very close to the estimated effect of treatment as reported in the conclusion in the literature.
  • The conclusion is very uncertain.

 

B) Questions concerning aetiology and prognosis

GRADE cannot be applied in this type of question. The strength of evidence of the conclusion is determined in accordance with the EBRO method (van Everdingen, 2004).

 

Formulating the conclusions

Evidence concerning questions about the value of diagnostic tests, injury or side effects, aetiology and prognosis, has been summarised in one or more conclusions in which the level of the most relevant evidence is given.

 

In questions relating to intervention and diagnosis, the conclusion does not refer to one or more articles, but is drawn on the basis of the whole body of evidence. In this the members of the working party did an analysis for each intervention. In making these calculations, the beneficial and unfavourable effects for the patient were weighed off against one other.

 

Considerations

In order to produce a recommendation, aspects other than research evidence are also important. These include the expertise of the members of the working party, patient preferences, costs, availability of facilities and organisational matters. In as far as they are not part of the literature summary, these aspects are reported under the heading ‘Considerations’.

 

Development of recommendations

The recommendations answer the clinical question and are based on the best available scientific evidence and the most important considerations. The strength of the scientific evidence and the weight accorded the considerations by the working party together determine the strength of the recommendation. In accordance with the GRADE methodology, a low grade of evidence from a conclusion in the systematic literature analysis does not exclude a strong recommendation, and a high grade of evidence does not exclude a weaker recommendation. The strength of the recommendation is always determined by weighing up all relevant arguments together.

 

Preconditions (Organisation of care)

In the analysis of problem areas and the development of the guidelines, account was taken explicitly of the organisation of care: all those aspects that are preconditions for the provision of care. These include coordination, communication, materials, financial means, work force and infrastructure. Preconditions that are relevant to the answering of a specific clinical question are part of the considerations related to that specific question.

 

Development of indicators

At the same time as the concept guidelines were developed, internal quality indicators were also developed in order to be able to follow and to strengthen the application of a guideline in practice. More information about the method of developing indicators can be requested from the secretariat of the Knowledge Institute of Medical Specialists (secretariaat@kennisinstituut.nl).

 

Knowledge gaps

In the development of these guidelines, we systematically searched for research whose results contributed to answering one of the clinical questions. The working party examined each clinical question and they considered the desirability of further research. An overview of their recommendations for further research can be seen in Knowledge gaps (see related products).

 

Comment and authorisation stage

To follow (after comment stage)

 

Implementation

At each stage of the development of the guidelines, account was taken of the implementation of the guidelines and the feasibility of the recommendations in practice. In this, particular attention was paid to factors that may advance or hinder the implementation of the guidelines.

Search strategy

Searches are available upon request. Please contact the Richtlijnendatabase.