Question

What postoperative antibiotic coverage should be given after reconstruction of an open fracture of the lower limb?

Recommendation

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

 

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

 

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

 

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

Introduction

Grade III open fractures of the lower limb are seldom ‘clean wounds’ and are often contaminated by dirt from the street or agriculture (Weber, 2015). Antibiotics should be administered as soon as possible after the injury in order to prevent infections. However, on reconstruction the wound should be cleaned and then closed. The question is does the postoperative administration of antibiotics lead to better outcomes, and if this is so how long should antibiotics be given? This module examines if the longer-term administration of antibiotics following fracture reconstruction is of any extra benefit.

Conclusions

No GRADE

There are a number of studies that conclude that there are indications that treatment with antibiotics (short or long term) reduces the risk of infection. The literature does not provide any clarity on the most effective duration of treatment.

 

Source (Isaac, 2015)

Literature summary

Description of studies

The review described the results from eight publications on four studies containing various cohorts. One study (two publications) had an RCT design. The majority of the studies had not been carried out recently (seven publications between 1976 and 1991, one in 2013). This is a possible explanation of why the results were only described very briefly in the review and original studies.

 

Gustillio, (1976) studied 1025 patients with various fractures. Antibiotics (type of antibiotic is not specified) were administered for three or seven to ten days. The study comprised various merged cohorts. In one cohort, 155 of the 352 patients were lost to follow-up (reason not stated).

 

Patzakis (1983, 1983b and 1989) and Wilkins (1991) studied a cohort of 1104 patients with grade I-III open fractures. A number of antibiotic protocols were tried out: 1) no antibiotics, 2) intravenous (IV) penicillin, (benzathinebenzyl penicillin) and streptomycin for five days. Streptomycin is an old antibiotic which belongs to the same class as gentamycin and tobramycin. Broad spectrum S aureus and also gram-negatives), 3) cefalotin (IV) for five days followed by five days of orally administered cephalexin, 4) cefalotin (IV) for five days and intramuscular (IM) aminoglycosides for three to five days. The operative treatment was not laid down in a protocol. Variation in operative procedures has possibly influenced the outcome on infections.

 

Dellinger, (1987 and 1988) carried out a randomised trial. Patients were given cefalotin for five days, cefamandol for five days on comparison with one day of cefalotin.

 

Dunkel, (2013) studied a cohort of 1492 patients which included 310 patients with a grade III open fracture. The study compares the administration of antibiotics for one, two to three, four to five or more than five days. The operations were carried out in accordance with a strict protocol.

 

Results

Gustilo found indications that patients who were given antibiotics for three days developed fewer infections than patients who had been given antibiotics for seven to ten days (statistically significant difference). However, this should be seen from the perspective that the choice to continue to treat with antibiotics is possibly related to the extent, degree of contamination and complexity of the open fracture. In the analysis these factors had not been corrected for.

 

Patzakis observed that the number of infections among patients who did not get antibiotics was two to five times higher than among patients who did get antibiotics. In Group 1 24% developed infections, in Group 2 this was 10.8%, in Group 3 13% and in Group 4, 4.5% developed infections. They concluded that eight days of antibiotics could be recommend for grade III fractures, prolonged for three days in the event of grafting of soft tissues and bone.

 

Dunkel reported a possible correlation between the number of infections and the duration of administration of antibiotics. Duration of treatment of one day was used as the reference value. The results showed that there was no significant relationship between number of infections and administration of antibiotics for longer than one day. The odds ratio was 0.6 (95% CI 0.2 to 2.0) for duration of treatment of two to three days, and 1.4 (95% CI 0.4 tot 4.4) for treatment lasting longer than five days.

 

No results on wound healing or side effects were reported.

 

Strength of evidence of the literature

The strength of evidence on the outcome infections has not been evaluated with GRADE as there are too many limitations in the study set-up, the heterogeneous study protocols and reporting of outcomes. These limitations mean that the results must be interpreted with extreme caution until the clinical question in this module can be tested in an RCT with a valid design.

Search and select

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

What are the favourable and unfavourable effects of long-term vs short-term administration of antibiotics following treatment of open fracture of the lower limb?

 

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

I: Antibiotics for more than three days from time of reconstruction;

C: Antibiotics for less than three days from time of reconstruction;

O: Infections, side effects, reoperations

 

Relevant outcome measures

The working party did not define the outcome measures in advance, but adopted the definitions used in the studies. The working party defined a change of 5% as being a clinically relevant difference.

 

Method of searching and selection

On 19 November 2015, the databases Medline (OVID) and Embase were searched for systematic reviews and controlled studies using relevant search terms. The search strategy is shown under the tab Justification. The literature search gave 127 hits, and one study that was not indexed at the time of the search. Studies were selected on the grounds of the following selection criteria: they were required to satisfy PICO criteria and be of an experimental or observational design. Studies whereby part of the patient group had a grade III open fracture of the lower limb were also included. Eight studies were preselected on the basis of title and abstract. After reading the complete text, seven studies were excluded (see exclusion table) and one study was definitively selected.

 

(Results)

One study, a systematic review was included in the literature analysis. The evidence tables and assessment of individual study quality can be found under the tab Evidence Base.

References

  1. Barton CA, McMillian WD, Crookes BA, Osler T, Bartlett CS 3rd. Compliance with the Eastern Association for the Surgery of Trauma guidelines for prophylactic antibiotics after open extremity fracture. Int J Crit Illn Inj Sci. 2012May;2(2):57-62. doi: 10.4103/2229-5151.97268. PubMed PMID: 22837892; PubMed Central PMCID: PMC3401818.
  2. Halawi MJ, Morwood MP. Acute Management of Open Fractures: An Evidence-Based Review. Orthopedics. 2015 Nov;38(11):e1025-33. doi: 10.3928/01477447-20151020-12. Review. PubMed PMID: 26558667.
  3. Hauser CJ, Adams CA Jr, Eachempati SR; Council of the Surgical Infection Society.. Surgical Infection Society guideline: prophylactic antibiotic use in open fractures: an evidence-based guideline. Surg Infect (Larchmt). 2006 Aug;7(4):379-405. Review. PubMed PMID: 16978082.
  4. Isaac SM, Woods A, Danial IN, et al. Antibiotic Prophylaxis in Adults With Open Tibial Fractures: What Is the Evidence for Duration of Administration? A Systematic Review. J Foot Ankle Surg. 2015
  5. Lingaraj R, Santoshi JA, Devi S, Najimudeen S, Gnanadoss JJ, Kanagasabai R, Kanungo R. Predebridement wound culture in open fractures does not predict postoperative wound infection: A pilot study. J Nat Sci Biol Med. 2015 Aug;6(Suppl 1):S63-8. doi: 10.4103/0976-9668.166088. PubMed PMID: 26604622; PubMed Central PMCID: PMC4630766.
  6. Weber D, Dulai SK, Bergman J, Buckley R, Beaupre LA. Time to initial operative treatment following open fracture does not impact development of deep infection: a prospective cohort study of 736 subjects. J Orthop Trauma. 2014 Nov;28(11):613-9. doi: 10.1097/BOT.0000000000000197. PubMed PMID: 25050748.
  7. Wilkins J, Patzakis M. Choice and duration of antibiotics in open fractures. Orthop Clin North Am. 1991 Jul;22(3):433-7. Review. PubMed PMID: 1852421.

Evidence tables

Study reference

Study characteristics

Patient characteristics

Intervention (I)

Comparison / control (C)

Follow-up

Outcome measures and effect size

Comments

Isaac, 2015

 

SR and meta-analysis of observational studies and RCTs

 

Literature search upwas not reported and update by the Knowledge institute on 19 November 2015

 

A: Gustillio 1976

B: Patzakis, 1983

C: Patzakis, 1983

D: Patzakis, 1989

E: Wilkins, 1991

F: Dellinger, 1987

G: Dellinger, 1988 (RCT)

H: Dunkel, 2013

 

Study design: Observational study data and RCTs

 

Country:

Not reported

 

Source of funding:

Not reported

Inclusion criteria SR: adults with open tibia fractures, receiving operative management and short or long-term antibiotics

 

Exclusion:

Studies reported in other languages than English, or sample size <20.

 

8 studies included

 

N

A: 1025

B: 109

C: 363 (including patients form study B)

D: 1104

E: -

F: 240

G: 248

H: 1492

 

Type of fracture

A: Gustillio I to III

B: open fractures

C: not reported

D: not reported

E: Gustillio I to III

F: open fractures

G: open fractures

H: Gustili I = 663,

Gustilio II = 370,

Gustilio III = 310 (149 not classified)

 

Groups comparable at baseline?

No, studies were not randomized and used different operation options

A: 7 to 10 days postoperative antibiotics

B: 3 days (5 days in patients with positive cultures)

C1: Intravenous penicillin and streptomycin for 10 days

C2: Intravenous cephalothin for 5 days follow by oral cephalexin for 5 days

C1: Intravenous cephalosporin and intramuscular aminoglycoside for 3 to 5 days

D: 3 tot 10 days with antibiotics

E: analysis on study B, C, D

F1: 5 days of cefonicid

F2: 5 days of cefamandole

G: 5 days of cefonicid

G2: 5 days of cefamandole

H: 2 to 3, 4 to 5, or >5 days antibiotics

 

A: 3 days postoperative antibiotics

B: -

C: no antibiotics

D: no antibiotics

E: analysis on study B, C, D

F: -

G: 1 day of cefonicid

H: 1 days of antibiotics

 

End-point of follow-up:

 

A: 155 out of 352 (not reported for cohort of 673 patients)

B: -

C: -

D: -

E: -

F: -

G: -

H: 1

 

 

 

Infection rate:

A: range between 5.24% to 11.85% (long term)

2.4% (short term)

Statistically significantly different

B: 4.5%

C1: 10.8% vs. 24%

C2: 13% vs. 24%

C3: 4.5% vs. 24%

D: -

E: -

F: -

G: 12% vs. 13

G2: 13% vs. 13%

H: compared to 1 day

2 to 3 days: OR=0.6 [0.2 to 2.0]

4 to 5 days: OR=1.2 [0.3 to 4.92]

> 5days: OR=1.4 [0.4 to 4.4]

 

 

Non-union:

A: only reported for short term antibiotic (13.6%)

B: 4.5%

C: not reported

D: -

E: -

F: -

G: -

H: -

 

A: High loss to follow up, different operative management strategies

B: Different operative management strategies

C: patients were also reported in study b

D: correlation found between the type of used antibiotics instead of duration. Increased infection rate for patients who received antibiotic >3 hours

E: concluded to give patients with grade I or II fractures a 3 day courses of antibiotics, grade III an extension of 5 days and in case of soft tissue transfer or bone grafting additional 72 hours (3 days)

F: patient inclusion has overlap with study G

G: RCT

H: -

 

 

Table of quality assessment for systematic reviews of RCTs and observational studies

Based on AMSTAR checklist (Shea et al.; 2007, BMC Methodol 7: 10; doi:10.1186/1471-2288-7-10) and PRISMA checklist (Moher et al 2009, PLoS Med 6: e1000097; doi:10.1371/journal.pmed1000097)

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/notapplicable

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

Isaac, 2015

Yes, pico stated

Unclear, but update with a search by the Knowledge institute to correct this

Yes, clearly reported criteria

Few characteristics were described resulting amongst other reasons also from the lack of info in the primary studies

No

Narratively

Yes, did not perform a meta-analysis

Yes

Not reported

 

Table Excluded after reading complete article

Author and year

Reasons for exclusion

Craig 2014

Compares systematic with local administration of antibiotics

Moehring 2000

Analysis of locally administered antibiotics

Zych 1995

A narrative review

Paiement 1994

Open ankle fracture

Torbert 2015

Antibiotic resistance

Lack 2015

Studies time to first administration following the accident

Gustilio 1976

Included in review

Considerations

The use of antibiotics in grade III open fractures varies greatly. Due to the lack of methodologically correctly designed studies, no recommendations concerning the choice of drug and the duration of treatment can be taken from the literature (Barton, 2015; Halawi, 2015). There is no indication for taking cultures on arrival at hospital (apart from exceptional contaminants). In the majority of cases, infections in open fractures are caused by bacteria found in hospitals (Staphylococcus aureus, Pseudomonas) and rarely by bacteria from elsewhere (Lingaraj, 2015).

 

When choosing an antibiotic, account should be taken of the pathogens most likely to cause postoperative infections. Staphylococcus aureus is the only pathogen whereby it has been conclusively established that treatment leads to fewer infections. There are no studies that conclusively demonstrate that the administration of antibiotics with a gram negative spectrum reduces the incidence of postoperative wound infections caused by gram-negative rods (e.g. E coli, Enterobacter spp, Pseudomonas). The recommendations concerning gram-negative cover are largely based on the studies of Patzakis, in which the data presented are not supported for gram-negative cover. However, usage originates in the publications of Gustilo who, in his initial studies into grade III open fractures, reported a high percentage of wound infections caused by Gram-negative organisms (Gustilo, 1984, Hauser 2006).

 

The treatment of Clostridium perfringens infections is recommended by various guidelines in which stratification is sometimes done on the basis of the degree and nature of contamination. Nevertheless, there is no indication that the number of Clostridium perfringens infections increases if Clostridium cover is absent from the treatment regimen. In exceptional circumstances, such as boat propeller injuries and those sustained in animal housing, other, more broad spectrum regimens can be used. These situations are not included in these guidelines. In a number of cases, treatment will be tailored to wound culture results. In these cases, it is advised to agree on treatment in consultation with a medical microbiologist. The management of an antibiotic switch (drug, duration of treatment) is not included in these guidelines.

 

With regard to the antibiotic spectrum, the following should be considered. In grade I/II fractures it has been shown that a regimen that covers only gram-positive pathogens (Staphylococcus aureus, streptococci) is adequate (Hauser, 2006). A broadening of the antibiotic spectrum whereby gram-negative pathogens are covered in the treatment of grade III open fractures is often implemented in daily practice, despite the lack of good evidence for this (Wilkins, 1991; Hauser, 2006). However, this usage originates from the publications of Gustilo who, in his initial studies into grade III open fractures, reported a high percentage of wound infections caused by gram-negative organisms (Gustilo, 1984, Hauser 2006). Despite the colonisation of wounds with gram-negative hospital flora (e.g. E coli, Enterobacter spp, Pseudomonas spp.) The role of these gram negative bacteria in the pathogenesis of infection is unclear (Hauser, 2006). Furthermore, there is no evidence that the addition of antibiotics with a gram-negative action reduces the incidence of wound infections in grade III fractures (Hauser, 2006).

 

Despite the lack of evidence, the working party suggests that in grade III fractures at least one drug that gives gram-positive cover should be given and that adding an extra drug should be considered (e.g. an aminoglycoside such as tobramycin, gentamicin or ciprofloxacin). A third-generation cephalosporin may also be used, although one potential disadvantage is that these drugs are less effective against S aureus.

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.

-

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.