DACC in the REduction of Surgical Site INfection (DRESSINg)

A Randomised Controlled Trial to Assess the Clinical and Cost 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.

Surgical site infection is an infection at a place in the body where surgery has taken place, and has been reported in around 5% of people undergoing an operation. In vascular surgery, infection rates are as high as 30%. Methods to reduce this rate of infection should be investigated thoroughly for their effectiveness and cost-effectiveness.

The investigators aim to conduct a research trial examining one such method. Leukomed Sorbact is a wound dressing coated with a chemical (DACC) derived from spider-silk that interacts with, and binds bacteria, causing them to be mechanically removed from a wound when the dressing is changed. The trial aims to compare the effectiveness of this dressing to a standard, non-coated dressing, in the reduction of surgical site infection.

718 patients from a number of centres across the UK will be recruited to this study. Adult patients who are having a vascular surgery operation will be approached for entry into the trial. The trial will be explained to them, as well as an explanation that participation is voluntary and their operation or other aspects of their care will not be impacted in any way should participants not wish to participate.

Participants will be randomised by computer into one of two groups - one group whose wounds are dressed with Leukomed Sorbact, and the other whose wounds are dressed with a standard dressing. Patients will be followed up at 30 days post-operatively. At the follow up, their wounds will be inspected for infection, and participants will be asked to complete short questionnaires measuring quality of life. Quality of life will also be assessed at 3 months post surgery.

The trial will aim to answer a number of questions, with the primary question being does a DACC coated dressing applied after an operation reduce the risk of an infection at the surgery site? It will also ask whether this treatment is cost-effective and whether it promotes satisfactory healing and evaluate the overall carbon footprint impact of each intervention.

Studies Within a Trial will be conducted to validate a remote diagnostic measure for detecting surgical site infection using wound images and the Bluebelle Wound Healing Questionnaire, evaluate feasibility of novel hair removal methods such as epilation and waxing, carbon footprint modelling within randomised controlled trials.

Study Overview

• Status: Recruiting
• Conditions: Surgical Wound; Wound Infection; Surgical Incision; Infection, Bacterial; Wound Infection, Surgical
• Intervention / Treatment: Device: DACC-Coated Post Operative Dressing

• Study Type: Interventional
• Enrollment (Estimated): 718
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ross Lathan, MbChB; Phone Number: 01482674643; Email: ross.lathan2@nhs.net
• Study Contact Backup: Name: Judith Long; Phone Number: 01482 675784; Email: judith.long3@nhs.net

Study Locations

• United Kingdom
  • East Riding Of Yorkshire
    • Hull, East Riding Of Yorkshire, United Kingdom, HU3 2JZ
      • Recruiting
      • Academic Vascular Surgery Unit, Vascular Laboratory, Alderson House, Hull Royal Infirmary
      • Contact: Ross Lathan, MbChB; Phone Number: 01482674643; Email: ross.lathan2@nhs.net
      • Principal Investigator: George E Smith, M.D.
      • Sub-Investigator: Ian C Chetter, M.D
      • Sub-Investigator: Joshua P Totty, MBBS
      • Sub-Investigator: Paris L Cai, MbChB
      • Sub-Investigator: Ross Lathan, MbChB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

In order to be eligible for inclusion in the study the participants must meet the following criteria:

• Adults ≥18 yrs undergoing clean or clean-contaminated lower limb vascular surgery, with wounds closed by primary intention.
• Able to understand the Patient Information Sheet and supplementary materials and capable and willing to give informed consent and follow the protocol requirements (including attending all follow-up visits and completing written questionnaires).

Exclusion Criteria:

Patients will not be included in the study if they meet any of the following exclusion criteria:

• Patients on antibiotics for other conditions at the time of surgery or in the follow up period.
• Patients undergoing any procedure that does not include lower limb incisions.
• Allergies to any component of either the DACC-coated dressing or the control dressing.
• Inability to give informed consent due to incapacity (as defined by the MCA 2005)
• Aged under 18 years at the time of recruitment
• Use of investigational drug/device therapy within preceding 4 weeks that may interfere with this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DACC-Coated Post-Operative Dressing	Device: DACC-Coated Post Operative Dressing; Leukomed Sorbact is a non-active coated wound dressing, containing Dialkylcarbomoylchloride. This is a bacteria-binding compound that adheres bacteria via hydrophobic interaction and removes them from the wound bed at dressing change.; Other Names: Leukomed Sorbact
No Intervention: Non-DACC coated Occlusive Post-operative Film Dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30 day infection rate	Surgical Site Infection at 30 days post-op	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	30-day mortality	30 days
3 month infection rate	Surgical Site Infection at 3 months post-op (implant patients only)	3 months
Quality of Life (SF-36 V2)	Score ranging from 0-100, higher values indicating better health	30 days, 3 months
Quality of Life (EQ-5D-3L)	Score ranging from 5-15, higher scores indicating worse health	30 days, 3 months
Bluebelle wound healing questionnaire	Score ranging 0-41, higher values indicating infection	Days 30 and 37
Carbon Footprint Analysis	Healthcare resource use data	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
SWAT 1 Validation Acceptability	Response rates to measure at 30 and 37 days	30 and 37 days
SWAT 1 Validation reliability	Inter and intra rater reliability	30 and 37 days
SWAT 1 Validation Validity	Sensitivity, specificity, ROC analysis, AUC	30 days
SWAT 2 Hair Removal Feasibility	Safety/adverse events	30 days
Carbon Footprint Model Development	Healthcare resource use data, consumable item weights	3 months

Collaborators and Investigators

• Sponsor: Hull University Teaching Hospitals NHS Trust
• Collaborators: University of Hull
• Investigators: Principal Investigator: George Smith, M.D, Hull University Teaching Hospitals NHS Trust

Publications and helpful links

General Publications

• Totty JP, Harwood AE, Cai PL, Hitchman LH, Smith GE, Chetter IC. 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. Pilot Feasibility Stud. 2019 Jan 18;5:11. doi: 10.1186/s40814-019-0400-2. eCollection 2019.

Helpful Links

• Abstract Link

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2017
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: December 12, 2016
• First Submitted That Met QC Criteria: December 13, 2016
• First Posted (Estimated): December 14, 2016

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Infection; Surgical Site Infection; Dialkylcarbamoylchloride
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Wounds and Injuries; Surgical Wound; Surgical Wound Infection; Wound Infection; Bacterial Infections
• Other Study ID Numbers: R2034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No