DRESSINg: DACC in the REduction of Surgical Site INfection

Sponsor
Hull University Teaching Hospitals NHS Trust (Other)
Overall Status
Recruiting
CT.gov ID
NCT02992951
Collaborator
University of Hull (Other)
718
1
2
95.4
7.5

Study Details

Study Description

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 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.

Condition or Disease Intervention/Treatment Phase
  • Device: DACC-Coated Post Operative Dressing
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
718 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Pilot Feasibility 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 and Cardiothoracic Surgery
Actual Study Start Date :
Jan 19, 2017
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: DACC-Coated Post-Operative Dressing

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

    Non-DACC coated Occlusive Post-operative Film Dressing

    Outcome Measures

    Primary Outcome Measures

    1. 30 day infection rate [30 days]

      Surgical Site Infection at 30 days post-op

    Secondary Outcome Measures

    1. 1 year infection rate [1 year]

      Surgical Site Infection at 1 year post-op (implant patients only)

    2. Quality of Life (SF-36 V2) [7 days, 30 days, 3 months, 6 months, 1 year]

    3. Quality of Life (EQ-5D-5L) [7 days, 30 days, 3 months, 6 months, 1 year]

    4. Mortality [30 days]

      30-day mortality

    5. Bluebelle wound healing questionnaire [Days 30 and 37]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Academic Vascular Surgery Unit, Vascular Laboratory, Alderson House, Hull Royal Infirmary Hull East Riding Of Yorkshire United Kingdom HU3 2JZ

    Sponsors and Collaborators

    • Hull University Teaching Hospitals NHS Trust
    • University of Hull

    Investigators

    • Principal Investigator: George Smith, M.D, Hull and East Yorkshire NHS Trust

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Hull University Teaching Hospitals NHS Trust
    ClinicalTrials.gov Identifier:
    NCT02992951
    Other Study ID Numbers:
    • R2034
    First Posted:
    Dec 14, 2016
    Last Update Posted:
    Nov 10, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hull University Teaching Hospitals NHS Trust
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 10, 2021