Non-sterile gloves and dressing versus sterile gloves, dressings and drapes for suturing of traumatic wounds in the emergency department: a non-inferiority multicentre randomised controlled trial

Abstract

BackgroundPatients with traumatic wounds frequently present to the ED. Literature on whether to treat these wounds sterile or non-sterile is sparse. Non-sterile treatment has the advantage of saving resources and costs, and could be of value in health settings where sterile materials are not readily available. Our objective was to compare the rate of wound infection after suturing traumatic lacerations with non-sterile gloves and dressings versus sterile gloves, dressings and drapes in the ED. We hypothesised that non-sterile gloves and dressings would be non-inferior to sterile gloves, dressings and drapes. The non-inferiority margin was set at 2%.MethodsA multicentre single-blinded randomised controlled trial testing for non-inferiority of non-sterile gloves and dressings versus sterile gloves, dressings and drapes for suturing of traumatic wounds was performed in 3 EDs in The Netherlands. Adults with uncomplicated wounds were included from July 2012 to December 2016. At the time of treatment, patient and wound characteristics and management were documented. The outcome was wound infection, which was identified during follow-up in the treating ED at 5–14 days postprocedure.ResultsFrom 2468 eligible patients, 1480 were randomised in a sterile (n=747) or non-sterile (n=733) protocol. Baseline characteristics were similar in both study arms. The observed wound infection rate in the non-sterile group was 5.7% (95% CI 4.0% to 7.5%) vs 6.8% (95% CI 5.1% to 8.8%) in the sterile group. The mean difference of the wound infection rate of the two groups was −1.1% (95% CI −3.7% to 1.5%).ConclusionAlthough recruitment ceased prior to reaching our planned sample size, the findings suggest that there is unlikely to be a large difference between the non-sterile gloves and dressings for suturing of traumatic wounds and sterile gloves, dressings and drapes for suturing of traumatic wounds in the ED.Trial registration numberNL 34798.078.11, NTR3541.

Application of Field Sterility to Safely Reduce Cost and Waste in Cleft Surgery

“…They did not use masks, caps, gowns, or shoe coverings when suturing wounds. Their study yielded an infection rate of 5.7% [95% confidence interval (CI) 4%–7.5%) in nonsterile group and 6.8% (95% CI 5.1%–8.8%) in the sterile group and did not find any evidence that nonsterile gowns, drapes, and gloves are associated with wound infection 11 . Worral assessed infection rates of simple skin laceration repair in a rural family practice 10 .…”

“…5 Similarly, when comparing studies for minor cutaneous procedures performed in the Emergency Department (ED) or at the General practitioner's (GP) clinic, simple laceration repair, or skin lesion excision, no difference in SSI was observed between sterile and nonsterile glove groups (as shown in Supplemental Digital Content, Table 2, http://links.lww.com/SCS/ F325). [6][7][8][9][10][11] Recent multicenter randomized controlled trial by Zwaans et al investigated wound infection rates after suturing traumatic lacerations with nonsterile gloves and dressing versus sterile gloves, dressings, and drapes in the ED. 11 They did not use masks, caps, gowns, or shoe coverings when suturing wounds.…”

“…[6][7][8][9][10][11] Recent multicenter randomized controlled trial by Zwaans et al investigated wound infection rates after suturing traumatic lacerations with nonsterile gloves and dressing versus sterile gloves, dressings, and drapes in the ED. 11 They did not use masks, caps, gowns, or shoe coverings when suturing wounds. Their study yielded an infection rate of 5.7% [95% confidence interval (CI) 4%-7.5%) in nonsterile group and 6.8% (95% CI 5.1%-8.8%) in the sterile group and did not find any evidence that nonsterile gowns, drapes, and gloves are associated with wound infection.…”

“…Their study yielded an infection rate of 5.7% [95% confidence interval (CI) 4%-7.5%) in nonsterile group and 6.8% (95% CI 5.1%-8.8%) in the sterile group and did not find any evidence that nonsterile gowns, drapes, and gloves are associated with wound infection. 11 Worral assessed infection rates of simple skin laceration repair in a rural family practice. 10 In his nonsterile group, he did not use masks, gloves, or surgical drapes, and applied nonsterile wound dressings.…”

Sterile versus non-sterile gloves for traumatic wounds in the ED

“…In their Emergency Medicine Journal paper, Zwaans et al present a randomised controlled trial that asked whether the use of non-sterile gloves and dressings affects risk of infection when suturing traumatic wounds in the ED 1…”