Dataset Information

Randomised controlled feasibility trial of standard wound management versus negative-pressure wound therapy in the treatment of adult patients having surgical incisions for hip fractures.

ABSTRACT:

Introduction

Deep wound infection is a catastrophic complication after hip fracture surgery. However, current understanding of infection rates in this population is limited. Many technologies such as incisional negative-pressure wound therapy (NPWT) show promise in reducing the rate of infection. This trial is a feasibility study looking to establish a value estimated with a greater precision of the rate of deep infection after hip fracture treatment in patients treated with NPWT versus standard dressing following hip fracture surgery.

Methods and analysis

A randomised controlled trial of 464 patients will be run across multiple centres. It is embedded in the World Hip Trauma Evaluation cohort study. Any patient over the age of 65 years having surgery for hip fracture is eligible unless they are being treated with percutaneous screw fixation. A web-based randomisation sequence will stratify patients by centre. Patients will be allocated to either NPWT or standard care on a 1:1 basis. The primary outcome measure is the Centre for Disease Control definition of deep infection at 30 days. Follow-up at 4 months will also assess deep infection and the core outcome dataset for hip fractures. This includes health-related quality of life (EQ-5D-5L), mobility, mortality and late complications such as further surgery. The primary analysis will be intention to treat.

Ethics and dissemination

Oxford C Research Ethics Committee granted ethical approval on 28/04/2017, 17/SC/0207. The results of this study will be reported in a peer-reviewed publication and inform the design of a future full-scale trial.

Trial registration number

ISRCTN55305726.

SUBMITTER: Masters JPM

PROVIDER: S-EPMC5898317 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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Publications

Randomised controlled feasibility trial of standard wound management versus negative-pressure wound therapy in the treatment of adult patients having surgical incisions for hip fractures.

Masters James P M JPM Achten Juul J Cook Jonathan J Dritsaki Melina M Sansom Lucy L Costa Matthew L ML

BMJ open 20180412 4

<h4>Introduction</h4>Deep wound infection is a catastrophic complication after hip fracture surgery. However, current understanding of infection rates in this population is limited. Many technologies such as incisional negative-pressure wound therapy (NPWT) show promise in reducing the rate of infection. This trial is a feasibility study looking to establish a value estimated with a greater precision of the rate of deep infection after hip fracture treatment in patients treated with NPWT versus ...[more]

PMID: 29654039

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Project description:IntroductionPatients with closed high-energy injuries associated with major trauma have surprisingly high rates of surgical site infection in incisions created during fracture fixation. One factor that may reduce the risk of surgical site infection is the type of dressing applied over the closed surgical incision. In this multicentre randomised clinical trial, negative-pressure wound therapy will be compared with standard dressings with outcomes of deep infection, quality of life, pain and disability.Methods and analysisAdult patients presenting to hospital within 72?hours of sustaining major trauma, requiring a surgical incision to treat a fractured lower limb, are eligible for inclusion. Randomisation, stratified by trial centre, open/closed fracture at presentation and Injury Severity Score (ISS) ?15?versus ISS ?16?will be administered via a secure web-based service using minimisation. The random allocation will be to either standard wound management or negative-pressure wound therapy.Trial participants will usually have clinical follow-up at the local fracture clinic for a minimum of 6 months, as per standard National Health Service practice. Diagnosis of deep infection will be recorded at 30 days. Functional, pain and quality of life outcome data will be collected using the Disability Rating Index, Douleur Neuropathique Questionnaire and Euroqol - 5 Dimension - 5 level (EQ-5D-5L) questionnaires at 3 months and 6 months postinjury. Further data will be captured on resource use and any late postoperative complications.Longer term outcomes will be assessed annually for 5?years and reported separately.Ethics and disseminationNational Research Ethics Committee approved this study on 16 February 2016 16/WM/0006.The National Institute for Health Research Health Technology Assessment monograph and a manuscript to a peer-reviewed journal will be submitted on completion of this trial. The results of this trial will inform clinical practice on the clinical and cost-effectiveness of the treatment of this injury.Trial registration numberISRCTN12702354; Pre-results.

Project description:ImportanceFollowing surgery to treat major trauma-related fractures, deep wound infection rates are high. It is not known if negative pressure wound therapy can reduce infection rates in this setting.ObjectiveTo assess outcomes in patients who have incisions resulting from surgery for lower limb fractures related to major trauma and were treated with either incisional negative pressure wound therapy or standard wound dressing.Design, setting, and participantsA randomized clinical trial conducted at 24 trauma hospitals representing the UK Major Trauma Network that included 1548 patients aged 16 years or older who underwent surgery for a lower limb fracture caused by major trauma from July 7, 2016, through April 17, 2018, with follow-up to December 11, 2018.InterventionsIncisional negative pressure wound therapy (n = 785), which involved a specialized dressing used to create negative pressure over the wound, vs standard wound dressing not involving negative pressure (n = 763).Main outcomes and measuresThe primary outcome measure was deep surgical site infection at 30 days diagnosed according to the criteria from the US Centers for Disease Control and Prevention. A preplanned secondary analysis of the primary outcome was performed at 90 days. The secondary outcomes were patient-reported disability (Disability Rating Index), health-related quality of life (EuroQol 5-level EQ-5D), surgical scar assessment (Patient and Observer Scar Assessment Scale), and chronic pain (Douleur Neuropathique Questionnaire) at 3 and 6 months, as well as other local wound healing complications at 30 days.ResultsAmong 1548 participants who were randomized (mean [SD] age, 49.8 [20.3] years; 561 [36%] were aged ≤40 years; 583 [38%] women; and 881 [57%] had multiple injuries), 1519 (98%) had data available for the primary outcome. At 30 days, deep surgical site infection occurred in 5.84% (45 of 770 patients) of the incisional negative pressure wound therapy group and in 6.68% (50 of 749 patients) of the standard wound dressing group (odds ratio, 0.87 [95% CI, 0.57 to 1.33]; absolute risk difference, -0.77% [95% CI, -3.19% to 1.66%]; P = .52). There was no significant difference in the deep surgical site infection rate at 90 days (11.4% [72 of 629 patients] in the incisional negative pressure wound therapy group vs 13.2% [78 of 590 patients] in the standard wound dressing group; odds ratio, 0.84 [95% CI, 0.59 to 1.19]; absolute risk difference, -1.76% [95% CI, -5.41% to 1.90%]; P = .32). For the 5 prespecified secondary outcomes reported, there were no significant differences at any time point.Conclusions and relevanceAmong patients who underwent surgery for major trauma-related lower limb fractures, use of incisional negative pressure wound therapy, compared with standard wound dressing, resulted in no significant difference in the rate of deep surgical site infection. The findings do not support the use of incisional negative pressure wound therapy in this setting, although the event rate at 30 days was lower than expected.Trial registrationisrctn.org Identifier: ISRCTN12702354.

Project description:Femoral head fractures are rare injuries; incongruency and instability are indications for surgical intervention. Anterior, posterior, and transtrochanteric surgical approaches have been proposed, but the exposure is limited with classical approaches. Surgical hip dislocation allows for a 360° view of the head and may facilitate a reduction in selected head fractures, but to our knowledge, few studies have reported on the results with this technique. We therefore report on the (1) quality of fracture reduction; (2) modified Harris hip score at a minimum of 2 years (mean, 6 years, range, 26-122 months); and (3) frequency of complications, including avascular necrosis (AVN), arthritis development, and heterotopic ossification, in a case series of patients with femoral head fractures treated with this approach.The procedure involves digastric trochanteric flip osteotomy and safe dislocation of the femoral head, preserving its vessels. Using this technique we are able to reduce all displaced femoral head fractures under direct view. Definitive fixation is performed through this approach with 2.7-mm nonabsorbable screws. The same technique may be used also for Pipkin IV fractures to fix transverse, T-type, posterior wall, or posterior column acetabular fracture.Between 2004 and 2011, we used this approach to manage all displaced femoral head fractures in patients younger than 55 years old. A total of 17 patients were thus treated; of those three were lost to followup before 2 years, and one was excluded from study because of severe preoperative neurological impairment, leaving 13 for analysis here. Patient demographic, injury, and surgical variables as well as complications were recorded and retrospectively evaluated. Radiographic outcome was scored according to Matta's criteria on postoperative radiographs. Outcomes were evaluated with the modified Harris hip score. Minimum followup was 24 months (mean, 77 months; SD, 32.8 months).Fracture reduction was anatomic in eight hips and imperfect in five. Mean clinical score was 82 points (SD, 7.7). One patient developed symptomatic femoral head AVN and underwent total hip arthroplasty 4 years after the index procedure; no other patient underwent arthroplasty. Besides this patient, signs of arthritis (Grade I according to Tönnis classification) were found in one patient and heterotopic ossification was recorded in two patients, but neither was symptomatic.Our experience with surgical dislocation shows clinical results comparable to previously reported outcomes in femoral head fractures treated with common approaches; we also present a similar rate of AVN and a lower rate of posttraumatic arthritis, but a higher risk of heterotopic ossification. Further case-control studies are necessary to confirm these statements.Level IV, therapeutic study.

Project description:ImportanceSurgical site infections (SSIs) are common after laparotomy wounds and are associated with a significant economic burden. The use of negative pressure wound therapy (NPWT) has recently been broadened to closed surgical incisions.ObjectiveTo evaluate the association of prophylactic NPWT with SSI rates in closed laparotomy incisions performed for general and colorectal surgery in elective and emergency settings.Data sourcesThe PubMed, Embase, Cochrane Central Register of Controlled Trials, and Google Scholar databases were searched without language restrictions for relevant articles from inception until December 2017. The latest search was performed on December 31, 2017. The bibliographies of retrieved studies were further screened for potential additional studies.Study selectionRandomized clinical trials and nonrandomized studies were included. Unpublished reports were excluded, as were studies that examined NPWT (or standard nonpressure) dressings only without a comparator group. Studies that evaluated the use of NPWT in open abdominal incisions were also excluded. Disagreement was resolved by discussion, and if the question remained unsettled, the opinion of the senior author was sought. A total of 198 citations were identified, and 189 were excluded.Data extraction and synthesisThis meta-analysis was conducted according to PRISMA guidelines. Data were independently extracted by 2 authors. A random-effects model was used for statistical analysis.Main outcomes and measuresThe primary outcome measure was SSI, and secondary outcomes included seroma and wound dehiscence rates. These outcomes were chosen before data collection.ResultsNine unique studies (3 randomized trials and 2 prospective and 4 retrospective studies) capturing 1266 unique patients were included. Of these, 1187 patients with 1189 incisions were included in the final analysis (52.3% male among 7 studies reporting data on sex; mean [SD] age, 52 [15] years among 8 studies reporting data on age). Significant clinical and methodologic heterogeneity existed among studies. On random-effects analysis, NPWT was associated with a significantly lower rate of SSI compared with standard dressings (pooled odds ratio [OR], 0.25; 95% CI, 0.12-0.52; P < .001). However, no difference in rates of seroma (pooled OR, 0.38; 95% CI, 0.12-1.23; P = .11) or wound dehiscence (pooled OR, 2.03; 95% CI, 0.61-6.78; P = .25) was found. On sensitivity analysis, focusing solely on colorectal procedures, NPWT significantly reduced SSI rates (pooled OR, 0.16; 95% CI, 0.07-0.36; P < .001).Conclusions and relevanceApplication of NPWT on closed laparotomy wounds in general and colorectal surgery is associated with reduced SSI rates but similar rates of seroma and wound dehiscence compared with conventional nonpressure dressings.

Project description:ObjectiveTo determine the effectiveness of closed incision negative pressure wound therapy (NPWT) compared with standard dressings in preventing surgical site infection (SSI) in obese women undergoing caesarean section.DesignMulticentre, pragmatic, randomised, controlled, parallel group, superiority trial.SettingFour Australian tertiary hospitals between October 2015 and November 2019.ParticipantsEligible women had a pre-pregnancy body mass index of 30 or greater and gave birth by elective or semi-urgent caesarean section.Intervention2035 consenting women were randomised before the caesarean procedure to closed incision NPWT (n=1017) or standard dressing (n=1018). Allocation was concealed until skin closure.Main outcome measuresThe primary outcome was cumulative incidence of SSI. Secondary outcomes included depth of SSI (superficial, deep, or organ/body space), rates of wound complications (dehiscence, haematoma, seroma, bleeding, bruising), length of stay in hospital, and rates of dressing related adverse events. Women and clinicians were not masked, but the outcome assessors and statistician were blinded to treatment allocation. The pre-specified primary intention to treat analysis was based on a conservative assumption of no SSI for a minority of women (n=28) with missing outcome data. Post hoc sensitivity analyses included best case analysis and complete case analysis.ResultsIn the primary intention to treat analysis, SSI occurred in 75 (7.4%) women treated with closed incision NPWT and in 99 (9.7%) women with a standard dressing (risk ratio 0.76, 95% confidence interval 0.57 to 1.01; P=0.06). Post hoc sensitivity analyses to explore the effect of missing data found the same direction of effect (closed incision NPWT reducing SSI), with statistical significance. Blistering occurred in 40/996 (4.0%) women who received closed incision NPWT and in 23/983 (2.3%) who received the standard dressing (risk ratio 1.72, 1.04 to 2.85; P=0.03).ConclusionProphylactic closed incision NPWT for obese women after caesarean section resulted in a 24% reduction in the risk of SSI (3% reduction in absolute risk) compared with standard dressings. This difference was close to statistical significance, but it likely underestimates the effectiveness of closed incision NPWT in this population. The results of the conservative primary analysis, multivariable adjusted model, and post hoc sensitivity analysis need to be considered alongside the growing body of evidence of the benefit of closed incision NPWT and given the number of obese women undergoing caesarean section globally. The decision to use closed incision NPWT must also be weighed against the increases in skin blistering and economic considerations and should be based on shared decision making with patients.Trial registrationANZCTR identifier 12615000286549.

Project description:IntroductionMetacarpal shaft fractures (MSF) are common traumatic hand injuries that usually affect young people of working age. They place a significant burden on healthcare resources and society; however, there is a lack of evidence to guide their treatment. Identifying the most beneficial and cost-efficient treatment will ensure optimisation of care and provide economic value for the National Health Service. The aim of this study is to assess the feasibility of a randomised controlled trial comparing surgical and non-surgical treatment for MSF in adults.Methods and analysisThis is a multicentre prospective cohort study, with a nested qualitative study consisting of patient interviews and focus groups, and an embedded factorial randomised substudy evaluating the use of text messages to maximise data collection and participant retention. The outcomes of interest include eligibility, recruitment and retention rates, completion of follow-up, evaluation of primary outcome measures, calculation of the minimal clinically important difference (MCID) for selected outcome measures and establishing the feasibility of data collection methods and appropriate time-points for use in a future trial. Data will be captured using a secure online data management system. Data analyses will be descriptive and a thematic inductive analysis will be used for qualitative data. Minimum clinically important effects for each patient-reported outcome measure will be estimated using anchor-based responsiveness statistics and distribution-based methods.Ethics and disseminationThis study has received ethical approval from the Research Ethics Committee and the Health Research Authority (REC reference 20/EE/0124). Results will be made available to patients, clinicians, researchers and the funder via peer-reviewed publications and conference presentations. Social media platforms, local media and feedback from the Patient Advisory Group will be used to maximise circulation of findings to patients and the public.Trial registration numberISRCTN13922779.

Dataset Information

Randomised controlled feasibility trial of standard wound management versus negative-pressure wound therapy in the treatment of adult patients having surgical incisions for hip fractures.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Randomised controlled feasibility trial of standard wound management versus negative-pressure wound therapy in the treatment of adult patients having surgical incisions for hip fractures.

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