Open AccessA pilot feasibility randomised clinical trial comparing dialkylcarbamoylchloride‐coated dressings versus standard care for the primary prevention of surgical site infection
Author(s) -
Totty Joshua P.,
Hitchman Louise H.,
Cai Paris L.,
Harwood Amy E.,
Wallace Tom,
Carradice Dan,
Smith George E.,
Chetter Ian C.
Publication year - 2019
Publication title -
international wound journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.867
H-Index - 63
eISSN - 1742-481X
pISSN - 1742-4801
DOI - 10.1111/iwj.13113
Subject(s) - medicine , randomized controlled trial , surgery , odds ratio , serous fluid , clinical trial , relative risk , clinical endpoint , confidence interval
A surgical site infection (SSI) may occur in up to 30% of procedures and results in significant morbidity and mortality. We aimed to assess the feasibility of conducting a randomised controlled trial (RCT) examining the use of dialkylcarbamoylchloride (DACC)‐impregnated dressings, which bind bacteria at the wound bed, in the prevention of SSI in primarily closed incisional wounds. This pilot RCT recruited patients undergoing clean or clean‐contaminated vascular surgery. Participants were randomised intraoperatively on a 1:1 basis to either a DACC‐coated dressing or a control dressing. Outcomes were divided into feasibility and clinical outcomes. The primary clinical outcome was SSI at 30 days (assessed using Centers for Disease Control criteria and Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of the deep tissues, Isolation of bacteria and duration of inpatient Stay scoring methods). This study recruited 144 patients in 12 months at a median rate of 10 per month. Eligibility was 73% and recruitment 60%. At 30 days, there was a 36.9% relative risk reduction in the DACC‐coated arm (16.22% versus 25.71%, odds ratio 0.559, P = 0.161). The number needed to treat was 11 patients. A large‐scale RCT is both achievable and desirable given the relative risk reduction shown in this study. Further work is needed to improve the study protocol and involve more centres in a full‐scale RCT.