A pilot feasibility randomised clinical trial comparing dialkylcarbamoylchloride‐coated dressings versus standard care for the primary prevention of surgical site infection

Abstract

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.

The impact of surgical site infection on hospitalisation, treatment costs, and health‐related quality of life after vascular surgery

“…The ASEPSIS scoring system was used to assess the wound between postoperative days 5 and 7 and at postoperative day 30 ± 3 days. For further details on data collection methods for the primary outcomes see Totty et al 11 During the study, data were also collected on a series of secondary outcomes, including antibiotic use, LOS, time taken to return to work, and readmission to hospital. At each study follow‐up time point, patient‐reported HRQoL was recorded using the EQ‐5D‐3L instrument 14…”

“…These records were not excluded from the primary outcomes analysis which focused on the feasibility of conducting a full RCT 11 . A final total of 136 patients were available for this analysis.…”

“…Data from 144 patients treated in a tertiary vascular surgery unit in the United Kingdom were collected to determine the impact of DACC-coated dressings on the incidence of SSI. 11 This study was conducted according to a previously published protocol. 12 Ethical approval was obtained (16/LO/2135), and the study conduct was in accordance with the Declaration of Helsinki.…”

“…A pilot randomised controlled trial (RCT) was conducted to examine the use of post-operative dressings coated with dialkylcarbamoyl chloride (DACC) in the prevention of SSI in primarily closed incisional wounds. 11 The study recruited patients undergoing clean or cleancontaminated vascular surgery. The primary clinical outcome was SSI at 30 days.…”

Prophylactic Closed Suction Drainage Is Irrelevant to Accelerated Rehabilitation after Open Reduction and Internal Fixation for Closed Distal Femur Fractures

“…However, an adverse effect of prophylactic CSD is that they may become a potential infection source and act as an infection path into the depths of the wound 9 . Some literature indicates that CSD plays an important role in the development of surgical site infection in orthopaedic trauma patients 10,11 . Besides this, according to a meta-analysis of the efficacy of CSD in orthopaedic patients, postoperative blood transfusion was required more frequently in those patients with drainage used 12 .…”