DACC in the REduction of Surgical Site INfection

NCT02992951 | Completed DMC

• 1 other identifier: R2034
• Study Type: interventional
• Target: 722
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound Infection, Surgical; Surgical Incision; Surgical Wound; Infection, Bacterial; Wound Infection

Keywords

Infection; Surgical Site Infection; Dialkylcarbamoylchloride

Outcome Measures

Primary Outcomes (1)

• 30 day infection rate

  Surgical Site Infection at 30 days post-op

  30 days

Secondary Outcomes (6)

• 3 month infection rate

  3 months

• Quality of Life (SF-36 V2)

  30 days, 3 months

• Quality of Life (EQ-5D-3L)

  30 days, 3 months

• Mortality

  30 days

• Bluebelle wound healing questionnaire

  Days 30 and 37

Other Outcomes (5)

• SWAT 1 Validation Acceptability

  30 and 37 days

• SWAT 1 Validation reliability

  30 and 37 days

• SWAT 1 Validation Validity

  30 days

Study Arms (2)

DACC-Coated Post-Operative Dressing

EXPERIMENTAL

DACC-Coated Post-Operative Dressing

Device: DACC-Coated Post Operative Dressing

Non-DACC coated Occlusive Post-operative Film Dressing

NO INTERVENTION

Non-DACC coated Occlusive Post-operative Film Dressing

Interventions

DACC-Coated Post Operative Dressing DEVICE

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.

Also known as: Leukomed Sorbact

DACC-Coated Post-Operative Dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead
• University of Hull: collaborator

Study Sites (1)

Academic Vascular Surgery Unit, Vascular Laboratory, Alderson House, Hull Royal Infirmary

Hull, East Riding of Yorkshire, HU3 2JZ, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 30680225 BACKGROUND

• Cristino MA, Nakano LC, Vasconcelos V, Correia RM, Flumignan RL. Prevention of infection in aortic or aortoiliac peripheral arterial reconstruction. Cochrane Database Syst Rev. 2025 Apr 22;4(4):CD015192. doi: 10.1002/14651858.CD015192.pub2.

  PMID: 40260835 DERIVED

Related Links

• Abstract Link

MeSH Terms

Conditions

Bacterial Infections; Wound Infection; Surgical Wound Infection; Surgical Wound; Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• George Smith, M.D

  Hull University Teaching Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2016
• First Posted: December 14, 2016
• Study Start: January 19, 2017
• Primary Completion: June 28, 2025
• Study Completion: August 31, 2025
• Last Updated: January 30, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)