Assessing the effectiveness of dialkylcarbamoylchloride (DACC)-coated post-operative dressings versus standard care in the prevention of surgical site infection in clean or clean-contaminated, vascular surgery (the DRESSINg trial): study protocol for a pilot feasibility randomised controlled trial

Abstract

Background: Surgical site infection in vascular surgery has a reported incidence of up to 19%. A novel method of reducing this rate of infection is dressings coated with dialkylcarbamoylchloride (DACC), a hydrophobic wound contact layer that binds bacteria and removes them from the wound bed. Early research has suggested that DACC-coated wound dressings are effective in reducing surgical site infection when applied to wounds healing by primary intention post-operatively, therefore this trial aims to assess the feasibility of producing high-quality evidence assessing this theory.

Methods: Patients undergoing clean or clean-contaminated vascular surgery will be randomised to have their surgical wounds dressed with a DACC-coated dressing or a non-coated occlusive absorbent post-operative dressing. All other aspects of their peri-operative care will be standardised or carried out in line with hospital policy. Wound assessments will be carried out between day 5-7, day 30 (± 3 days) and 6 months post-operatively (± 7 days) by a blinded assessor using the ASEPSIS scoring tool. Quality of life data using EQ-5D and SF-36, resource use and mortality data will also be collected. This feasibility trial will dictate the conduct of a full-scale trial through the collection of data on recruitment and retention rates, and fitness-for-purpose of the follow-up arrangements.

Discussion: Surgical site infections are now the second most common hospital acquired infections with a significant cost implication. The aim of the DRESSINg trial is to investigate the effectiveness of a novel preventative measure at reducing wound infections post-surgery and will provide robust evidence to support or deny its use.

Trial registration: Clinicaltrials.gov identifier: NCT02992951, Registered 12/12/16. REC Reference: 16/LO/2135.

Keywords: DACC; Dialkylcarbamoylchloride; Infection; Prevention; Surgery; Surgical wound.

Conflict of interest statement

Ethical approval was granted by London—Harrow Research Ethics Committee on 23/11/2016. REC reference 16/LO/2135 with the IRAS project ID 215973. The Research Protocol, patient information sheet and informed consent form have been approved by the Hull and East Yorkshire Hospitals NHS Trust Research and Development department (R2034). Informed consent via an information sheet and signed consent form is gained before enrolment into the trial, and the presence of a valid, signed and dated informed consent form is required for participation in the trial. All enrolled participants will have access, should they request it, to the full study protocol, and any publication of the final results.The participant information sheet, which has been approved by the Research Ethics Committee, provides information that the results will be submitted for publication in a scientific journal and a final report written. Participants will not be identified in any of the reports or publications. Co-authorship will be assigned according to the *Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals, Updated December 2015 of the International Committee of Medical Journal Editors.The authors declare that they have no competing interests.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1

Study flow chart. The target sample size for the pilot phase of this study is 144. Treatment and follow-up will run concurrently, giving a total time of 24 months from study start to completion