Open fractures of the lower limb

Initiative: NVVH Number of modules: 15

Definitive treatment of soft tissue injuries

Question

When should definitive reconstruction of soft tissue injuries in patients with open fracture of the lower limb take place?

Recommendation

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

 

Definitive fixation should be carried out at the same session as the definitive coverage of the soft tissues.

Considerations

A meta-analysis of observational data shows that the timing of definitve closure of the soft tissues is important in reducing the risk of infections and complications. After initial debridement, coverage is essential.

 

However, although analysis of the literature does not reveal a specific relationship between time and complications, timing appears important in that coverage within a week gives the best results.

 

It should be noted that following initial debridement and stabilisation, tissue necrosis may still progress because damage to the soft tissues is often underestimated. This is applicable not only to Gustilo III fractures but also to Gustilo II. The patient should be seen by a plastic surgeon and a plan formulated at an early stage. Soft tissue problems must also be considered at an early stage if a fracture or fixation material is likely to become exposed.

 

In the lower limb it is possible not to have to cover the injury acutely. However, one of the reasons for acute coverage is an exposed vascular anastomosis. That is to say, after an arterial injury has been be repaired it cannot be left uncovered as there is a high risk of leakage of the anastomosis or thrombosis.

 

Presenting a patient with a fracture that has been exposed for more than three or four weeks for surgery is completely outdated. This leaves the patient waiting needlessly, often even for transfer, meaning that the risk of short and long term complications increases. The experience of the working party is that carrying out microsurgery between two and six weeks following injury is unfavourable due to coagulopathy and vulnerable vessels that are easily damaged and thrombose during microsurgical procedures.

 

Ultimately, the type of coverage is not important as long as it is effective. It is not important if coverage is provided by a fasciocutaneous flap or a free muscle flap. In high-energy injuries, coverage with a free flap is often the best choice. This is certainly true of injuries to the distal third of the tibia. However, due to the time requirements of the operation, the organisation and planning of a free flap procedure is more complicated and makes large demands of the plastic and reconstructive departments.

 

The guidelines from the BOA and BAPRAS (2009) have the same targets based on the same grounds.

Evidence

In open fracture of the lower limb, good care of the soft tissues is of the greatest importance. Early initial debridement and good temporary soft tissue coverage until definitive coverage are essential. The essence of the matter is definitive coverage should not be unnecessarily delayed and dressings should only be used for a short time.

 

The adage says that bone starts to heal as soon as it is covered. Definitive coverage can be done as soon as the physiology of the patient permits it. Unnecessary delay because there is no plastic surgeon in the team is obsolete in this day and age, and fast referral is essential. Currently, the treatment of open fractures of the lower limb is characterised by large variations in practice and varying degrees of success in collaboration between treating professionals.

Very low GRADE

There are indications that delay in closure of the soft tissues may lead to an increased risk of complications, including the risk of infection.

 

Source (Wood, 2012)

Description of studies

A total of four studies were found to be relevant to this clinical question. These were one systematic review of prospective and retrospective cohort studies and three further cohort studies that were published after the systematic review. All studies concerned patients with a fracture of the extremities in combination with an open wound. The majority of the studies concerned tibial fracture type IIIA/B (Gustilo-Anderson). The majority of the studies followed treatment with internal or external fixation and the closure of soft tissues by means of autologous tissue transplant. The studies described the effects of early closure of the soft tissues and compared these with later closure of the soft tissues. All studies were observational.

 

All included studies compared early and late wound closure, but the definitions of ‘early’ and ‘late’ differed in each study. Early closure varied from closure directly after initial debridement in one study to closure within a period of 0-15 days in another. Late closure varied from 72 hours to three months.

 

Concerning the outcome measure complications (including infection), the meta-analyses of the systematic review have actualised. Other outcome measures (e.g. time to consolidation, length of hospital stay or time to complete weight bearing) are described per study where applicable.

 

Results

The majority of the studies reported on the positive effects of early closure of the wound in the area of prevention of complications, including infection. In other outcomes too (bone union, length of hospital stay and time to complete weight bearing), early closure of the wound appears to have a positive effect, but no quantitative data on this are available. A meta-analysis of the results shows a significantly lower risk of infection (RR=0.29; 95% CI of 0.19 to 0.44; I2=18%) and complications (RR=0.45; 95% CI 0.23 to 0.90; I2=50%) in favour of early closure of the soft tissues.

 

Meta-analysis of the relative risk of infections in early closure of the soft tissues compared with late closure of the soft tissues

Figure 1 Meta-analysis of the relative risk of infections in early closure of the soft tissues compared with late closure of the soft tissues. The definition of early and late differs across studies. The results show a clinically significant difference in favour of early closure of the soft tissues.

 

Meta-analysis of the relative risk of complications in early closure of the soft tissues compared with late closure of the soft tissues

Figure 2 Meta-analysis of the relative risk of complications in early closure of the soft tissues compared with late closure of the soft tissues. The definition of early and late differs across studies. The results show a clinically statistically significant difference in favour of early closure of the soft tissues.

 

Strength of evidence of the literature

Due to the observational character of the studies, the strength of evidence for the outcome measure infection began low. The strength of evidence was then lowered by one level due to the limitations of the design of the primary studies and the differences between the studies in the definition of type of intervention, monitoring and outcome measures. There is also a high risk of selection bias, namely that wound closure is done earlier in patients who are in a better state of health. There appears to be no suggestion of conflicting results, indirectness, imprecision or publication bias.

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

What are the favourable and unfavourable effects of closure of the soft tissues within two weeks versus beyond six weeks in patients with an open fracture of the lower limb?

 

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

I: Treatment within two weeks

C: Treatment beyond six to eight weeks

O: Chronic infection

 

Relevant outcome measures

The working party judged infection, consolidation, length of hospital stay to be outcomes critical to the decision-making process, and other complications to be important in the decision-making process.

 

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

 

Method of searching and selection

On 23 April 2015, using relevant search terms, the databases Medline (OVID) and Embase were searched for systematic reviews, randomised controlled studies (RCTs), and observational studies. The search strategy is shown under the tab Justification. The literature search resulted in 564 hits. Studies were selected on the grounds of the following selection criteria: the study included adult patients with grade III open fracture of the lower limb and whereby a comparison was made between closure of the soft tissues within two weeks and closure after a longer period. The study should include outcomes on the number of infections, consolidation, length of hospital stay and other complications. Studies giving a narrative description of daily practice (case series), studies in which time is included as a prognostic factor, and cadaver studies were excluded. Thirteen studies were preselected on the basis of title and abstract. After reading the complete text, nine studies were excluded (see exclusion table) and four studies were definitively selected.

  1. British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS). Standard for the management of open fractures of the lower limb. British Library Cataloguing in Publication Data 2009. ISBN: 978-1-85315-911-4
  2. Wood T, Sameem M, Avram R, et al. A systematic review of early versus delayed wound closure in patients with open fractures requiring flap coverage. J Trauma Acute Care Surg. 2012;72(4):1078-85.

Research question: Early vs delayed wound closure

Study reference

Study characteristics

Patient characteristics

Intervention (I)

Comparison / control (C)

Follow-up

Outcome measures and effect size

Comments

 

Wood, 2012

 

 

SR and meta-analysis of cohort studies

 

Literature search up to July 2010, updated up to April 2015.

 

A: Byrd 1985

B: Cierny 1983

C: Fischer 1991

D: Francel 1992

E: Godina 1986

F: Gopal 2000

G: Gopal 2004

H: Hertel 1999

I: D’Alleyrand 2014*

J: Jenkinson 2014*

K: Liu 2012*

 

Study design: Prospective/retrospective cohort

 

Setting and Country:

A: US

B: US

C: US

D: US

E: SI

F: GB

G: GB

H: CH/GB

I: US

J: CA

K: AU

 

Source of funding:

unclear

 

Inclusion criteria SR: 1) following patients with surgical repair of an open fracture requiring flap coverage.

2) review article or a comparative study evaluating the timing of wound coverage for open fractures.

3) clinical outcome marker to evaluate timing of wound coverage.

4) unpublished data from studies fulfilling criteria 1 or 2.

 

Exclusion criteria SR: 1) examining nonliving populations or animal studies.

2) management using primary closure methods

3) used nonsurgical methods for fracture management.

4) studied other variables outside of timing of flap coverage in open fracture injuries.

 

20 studies included of which 7 comparative studies included in meta-analyses; 3 studies added in update.

 

Important patient characteristics at baseline:

 

N, mean age

A: 18 patients

B: 36 patients

C: 43 patients

D: 532 patients

E: 80 patients

F: 33 patients

G: 29 patients

H: 69 patients (74 flaps), 39 yrs

I: 146 patients, 41 yrs

J: 103 patients (105 flaps), 42 yrs

 

Type of fracture

A:Open tibial type III/IV4

B:Open tibial type III/IIIa

C:Open tibial type IIIb

D: Open tibial type IIIb

E:Complex trauma of extremities

F: Open tibial type IIIb/IIIc

G: Open tibial type IIIb/IIIc
H
:Open tibial type IIIb/IIIc

I:Open tibial type IIIb

J:Open extremity I/II/IIIa

K: Lower limb type IIIa/IIIb/IIIc

 

Groups comparable at baseline?

Not stated, as Newcastle-Ottawa scores are not specified.

Describe intervention:

Early wound closure

A: 0-5d delay

B: 0-7d delay

C: 0-10d delay

D: <15d delay

E: 0-72h delay

F: 0-24h & 24-72h

G: 0-24h & 24-72h

H: immediate

I: 1-7d delay

J: immediate (after first debridement, av. 9h delay)

K: 0-3d delay

Describe control:

Delayed wound closure

A: 5-7d delay

B: 7-30d delay

C: 10d-6w & >6w delay

D: 15-30 & ≥31d

E: 72h-3m**

F: >72h delay

G: >72h delay

H: 1-9d delay

I: >7d delay

J: delayed (unknown delay, after ≥2 debridements)

K: 4-7d & >7d delay

End-point of follow-up:

A: not mentioned

B: av. 7w

C: av. 104w

D: min 1y, av. 42m

E: not mentioned

F: not mentioned

G: av. 46m

H: av. 47m

I: 3m

J: 12m

K: 12m

 

 

Outcome measure-1

Defined as infection rates:

A: osteomyelitis

B: deep & superficial infection

C: deep infection & osteomyelitits

E: postoperative infection

F: skin infection & deep infection

G: superficial infection & deep infection

H: bone infection

J: deep bone & tissue infection

K: deep metal infection & osteomyelitis

 

Effect measure: RR [95% CI]:

A: 1.60 [0.43, 6.05]

B: 0.19 [0.06, 0.58]

C: 0.30 [0.12, 0.73]

E: 0.14 [0.03, 0.56]

F: 0.26 [0.13, 0.50]

G: 0.45 [0.16, 1.28]

H: 0.12 [0.01, 2.02]

J: 0.23 [0.07, 0.78]

K: 0.23 [0.06, 0.87]

 

Pooled effect (random effects model):

RR: 0.29 [0.19, 0.44] favoring early wound closure

Heterogeneity (I2): 18%

 

Outcome measure-2

Defined as complication rates

A: free-flap failure

B: amputation

C: unknown

D: reexploration, loss of free flap, chronic osteomyelitis, superficial infection, partial loss of skin graft

E: free-flap failure,

F: overall flap loss, delayed union, amputation

K: flap take-back, flap failure, deep metal infection, osteomyelitits, non-weight bearing 1yr, non-union 1yr

 

Effect measure: RR, RD, mean, difference [95%CI]

A: 0.41 [0.19, 0.91]

B: 0.13 [0.02, 1.00]

C: 1.18 [0.08, 16.78]

D: 0.82 [0.47, 1.43]

E: 0.07 [0.01, 0.51]

F: 0.33 [0.05, 2.22]

K: 0.84 [0.26, 2.75]

 

Pooled effect (random effects model):

RR: 0.45 [0.23, 0.90] favouring early wound closure

Heterogeneity (I2): 50%

 

Facultative:

Brief description of author’s conclusion:

“Based on the results of this systematic review, it is clear that aggressive flap coverage that occurs in the “early” phase, as defined by our systematic review, provides optimal results in terms of bone union, infection, and complication rates in addition to minimizing hospital stays.” (p1082, par. 1)

 

Limitations of this review were the differences in types of injuries; types of flaps; definitions of the timing of wound closure (early: 0-15d; delayed: 3d-3m); end-point of follow-up; lack of information on complete outcome data available and definitions of infection and complications in the primary studies

 

All numbers were checked in the primary studies (except for the study of Fischer 1991 of which no full-text was available). Differences were found between the numbers in the meta-analysis of Wood 2012 for the study of Byrd 1985. The numbers of the primary studies were used in the update of the meta-analysis.

 

Quality assessment of individual studies (Newcastle-Ottawa scale):

A: 7

B: 5

C: 7

D: 7

E: 7

F: 6

G: 5

H: 7

I: N/A

J: N/A

K: N/A

 

Heterogeneity: the majority of point estimates of the studies indicate superior outcomes for early wound closure, although not all results were significant. I2 was 18% for infection rates and 50% for complication rates.

 

No subgroup analyses were performed as the majority of the point estimates indicated superior outcomes for early wound closure.

 

$ No Gustilo-Anderson classification but own classification

** In meta-analysis the group with wound closure >3m is omitted

 

* = studies added to the meta-analyses of Wood et al. in the guideline development update


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

Wood

Yes

Yes, search in multiple database using broad search terms.

No, only included studies were described.

Yes, type of fracture, study design and risk of bias.

No, not all included studies did correct for possible confounding.

Yes

Yes, even though there was heterogeneity in timing, the outcomes were homogeneous in the direction of results.

No

Yes, there are no conflicts of interests to declare.

 

Table Excluded after reading complete article

Author and year

Reason for exclusion

Srour, 2015

Comparison within 24h

Wei, 2014

Comparison<6h vs. >6h and mixed population of open fractures (also arm and ankle)

Ibrahim, 2014

Children

Matos, 2013

Comparison <24h vs.> 24h.

Yusof, 2012

No results for various treatment points.

Enninghorst, 2011

Comparison <6h vs.> 6h and no outcomes given.

Pollak

Timing of debridement

Franken

No comparisions between treatment points.

Steiert, 2009

Included in included review (Wood et al. 2012)

Authorization date and validity

Last review  : 01-01-2017

Last authorization  : 01-01-2017

Planned reassessment  : 01-01-2020

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.

Samenstelling werkgroep

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.

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Amputation of open limb fractures