Standard wound management versus negative-pressure wound therapy in the treatment of adult patients having surgical incisions for major trauma to the lower limb-a two-arm parallel group superiority randomised controlled trial: protocol for Wound Healing in Surgery for Trauma (WHIST).

INTRODUCTION: Patients 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 ANALYSIS: Adult 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 DISSEMINATION: National 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 NUMBER: ISRCTN12702354; Pre-results.

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: 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.

A systematic review of alternative splinting versus complete plaster casts for the management of childhood buckle fractures of the wrist.

Paediatric wrist-buckle fractures are common distal radius fractures with inherent stability. Traditional management with complete plaster-cast immobilization necessitates follow-up visits, time off school/work and hospital treatment costs. Treatment with alternative splinting, negating the need for follow-up visits and saving time and money, has been proposed. However, concerns with regard to complications, primarily pain, have been raised; hence, the topic remains controversial. A systematic review was performed with eight randomized-controlled trials analysed. Alternative splinting was superior to casting in terms of function, cost and convenience, but with no significantly worse pain or fracture complication level. The evidence endorses the use alternative splinting over casting in paediatric wrist-buckle fractures.

A systematic review of the evidence for single stage and two stage revision of infected knee replacement.

BACKGROUND: Periprosthetic infection about the knee is a devastating complication that may affect between 1% and 5% of knee replacement. With over 79 000 knee replacements being implanted each year in the UK, periprosthetic infection (PJI) is set to become an important burden of disease and cost to the healthcare economy. One of the important controversies in treatment of PJI is whether a single stage revision operation is superior to a two-stage procedure. This study sought to systematically evaluate the published evidence to determine which technique had lowest reinfection rates. METHODS: A systematic review of the literature was undertaken using the MEDLINE and EMBASE databases with the aim to identify existing studies that present the outcomes of each surgical technique. Reinfection rate was the primary outcome measure. Studies of specific subsets of patients such as resistant organisms were excluded. RESULTS: 63 studies were identified that met the inclusion criteria. The majority of which (58) were reports of two-stage revision. Reinfection rated varied between 0% and 41% in two-stage studies, and 0% and 11% in single stage studies. No clinical trials were identified and the majority of studies were observational studies. CONCLUSIONS: Evidence for both one-stage and two-stage revision is largely of low quality. The evidence basis for two-stage revision is significantly larger, and further work into direct comparison between the two techniques should be undertaken as a priority.

Anabolic steroids in patients undergoing total knee arthroplasty.

OBJECTIVES: To systematically review the evidence for using anabolic-androgenic steroids (AAS) to aid rehabilitation following total knee replacement (TKR). DESIGN: Systematic review of all clinical study designs. DATA SOURCES: MEDLINE, EMBASE, AMED, CINAHL and the Cochrane Library were searched from inception to August 2012. ELIGIBILITY CRITERIA: All clinical study designs without language or patient demographic limits. OUTCOME MEASURES: All functional, physiological and administrative outcomes as well as reporting of adverse events. RESULTS: Only two small randomised controlled trials satisfied the inclusion criteria. Statistically significant improvements were reported in the AAS group for quadriceps strength at 3 (p=0.02), 6 (p=0.01) and 12 (p=0.02) months, Functional Independence Measure score at 35 days (p=<0.05) and Knee Society Score at 6 weeks (p=0.02), 6 months (p=0.04) and 12 months (p=0.03). However, differences in hamstring strength, bone mineral density, sit-to-stand testing, walking speed, length of hospital stay and need for further inpatient rehabilitation did not reach statistical significance. There were no reported adverse events. CONCLUSIONS: There is insufficient evidence to recommend routine administration of AAS to patients undergoing TKR. However, pilot data suggest that AAS can be administered safely and may improve important postoperative outcome measures. This justifies a randomised trial sufficiently powered to identify between-group differences likely to be of clinical significance.