Bluebelle pilot randomised controlled trial of three wound dressing strategies to reduce surgical site infection in primary surgical wounds

Abstract

ObjectiveSurgical site infection (SSI) affects up to 25% of primary surgical wounds. Dressing strategies may influence SSI risk. The Bluebelle study assessed the feasibility of a multicentre randomised controlled trial (RCT) to evaluate the effectiveness and cost-effectiveness of different dressing strategies to reduce SSI in primary surgical wounds.DesignA pilot, factorial RCT.SettingFive UK hospitals.ParticipantsAdults undergoing abdominal surgery with a primary surgical wound.InterventionsParticipants were randomised to ‘simple dressing’, ‘glue-as-a-dressing’ or ‘no dressing’, and to the time at which the treatment allocation was disclosed to the surgeon (disclosure time, before or after wound closure).Primary and secondary outcome measuresFeasibility outcomes focused on recruitment, adherence to randomised allocations, reference assessment of SSI and response rates to participant-completed and observer-completed questionnaires to assess SSI (proposed primary outcome for main trial), wound experience and symptoms, and quality of life (EQ-5D-5L).ResultsBetween March and November 2016, 1115 patients were screened; 699 (73.4%) were eligible and approached, 415 (59.4%) consented and 394 (35.3%) were randomised (simple dressing=133, glue=129 and ‘no dressing’=132). Non-adherence to dressing allocation was 2% (3/133), 6% (8/129) and 15% (20/132), respectively. Adherence to disclosure time was 99% and 86% before and after wound closure, respectively. The overall rate of SSI (reference assessment) was 18.1% (51/281). Response rates to the Wound Healing Questionnaire and other questionnaires ranged from >90% at 4 days to 68% at 4–8 weeks.ConclusionsA definitive RCT of dressing strategies including ‘no dressing’ is feasible. Further work is needed to optimise questionnaire response rates.Trial registration number49328913; Pre-results.

The community burden of surgical site infection following elective colorectal resection

“…A strength of this study is that the questionnaire response rate was excellent at 81.3% using a combined approach of postal and telephone follow-up. Although it is a single centre study, it is the largest series of SSI after colorectal resection in the UK and the SSI rates align with other research studies where SSI rates have been measured with robust follow-up [13][14][15].…”

“…Patients with SSI had 8.03 interactions with community healthcare professionals compared to 3.26 in those without SSI. The Bluebelle study used a validated questionnaire to identify SSI followed by a face‐to‐face follow‐up [14] and reported a rate of 18.1% in patients having abdominal surgery. An intensive 30‐day postoperative surveillance programme in Spain in 13 000 patients found an SSI rate of 20.7% [15].…”

Effectiveness of moist dressings in wound healing after surgical suturing: A Bayesian network meta‐analysis of randomised controlled trials

“…The authors from 16 different countries applied 12 diverse dressings to sutured wounds. One of the arms in a three‐arm study 14 was removed for no dressing was applied. In terms of risk and bias assessment, half of the studies retained some concerns in the randomization process, 37.5% of studies retained some concerns in deviations from intended interventions, and 75% of studies retained some concerns in the measurement of the outcome.…”

“… 31 However, in a best practice, 93% of wound experts recommended that the decisive factor in choosing silver dressings is the release of silver ions, not the form of silver (e.g., ionic or metallic). 32 One RCT 14 creatively applied glue as a dressing on sutured wounds. According to our results, glue dressing was only better than silver nylon and gauze dressings in preventing SSIs.…”

“…Two studies related to skin grafts were excluded in that the compatibility of donor and recipient sites could affect wound healing. Ultimately, 16 studies [11][12][13][14][15][16][17][18][19][20][21][22][23][24][25][26] met the inclusion and exclusion criteria.…”