DACC in the REduction of Surgical Site INfection

Study Overview
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Brief Summary
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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 5-7 days and 30 days, and at 1 year. At the follow up, their wounds will be inspected for infection, and participants will be asked to complete short questionnaires measuring quality of life. 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. A Study Within a Trial will validate a remote diagnostic measure for detecting surgical site infection using wound images and the Bluebelle Wound Healing Questionnaire.

Official Title
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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.

Conditions
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Infection, Bacterial, Wound Infection, Wound Infection, Surgical, Surgical Incision, Surgical Wound

Intervention / Treatment
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* Device: DACC-Coated Post Operative Dressing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DACC-Coated Post-Operative Dressing<br>DACC-Coated Post-Operative Dressing | Device: DACC-Coated Post Operative Dressing<br>* 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.<br>* Other names: Leukomed Sorbact;|
| No Intervention: Non-DACC coated Occlusive Post-operative Film Dressing<br>Non-DACC coated Occlusive Post-operative Film Dressing | |

What is the study measuring?
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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 |
| --- | --- | --- |
| 1 year infection rate | Surgical Site Infection at 1 year post-op (implant patients only) | 1 year | 
| Quality of Life (SF-36 V2) |  | 7 days, 30 days, 3 months, 6 months, 1 year | 
| Quality of Life (EQ-5D-5L) |  | 7 days, 30 days, 3 months, 6 months, 1 year | 
| Mortality | 30-day mortality | 30 days | 
| Bluebelle wound healing questionnaire |  | Days 30 and 37 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infection, Surgical Site Infection, Dialkylcarbamoylchloride