DACC in the REduction of Surgical Site INfection

Not Applicable

Recruiting

• Conditions: Surgical Wound; Infection, Bacterial; Wound Infection, Surgical; Wound Infection; Surgical Incision
• Interventions: Device: DACC-Coated Post Operative Dressing

• Registration Number: NCT02992951
• Lead Sponsor: Hull University Teaching Hospitals NHS Trust

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-12
• Study First Submitted QC: 2016-12-13
• Study First Posted: 2016-12-14
• Study Start: 2017-01-19
• Status Verified: 2024-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-13
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 718

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DACC-Coated Post-Operative Dressing	DACC-Coated Post Operative Dressing	DACC-Coated Post-Operative Dressing

Primary Outcome Measures

Name	Time	Method
30 day infection rate	30 days	Surgical Site Infection at 30 days post-op

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Academic Vascular Surgery Unit, Vascular Laboratory, Alderson House, Hull Royal Infirmary; 🇬🇧 Hull, East Riding Of Yorkshire, United Kingdom