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DACC in the REduction of Surgical Site INfection (DRESSINg)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02992951
Recruitment Status : Completed
First Posted : December 14, 2016
Last Update Posted : July 2, 2019
Sponsor:
Collaborator:
University of Hull
Information provided by (Responsible Party):
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.

712 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
Infection, Bacterial Wound Infection Wound Infection, Surgical Surgical Incision Surgical Wound Device: DACC-Coated Post Operative Dressing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 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 : January 19, 2017
Actual Primary Completion Date : August 1, 2018
Actual Study Completion Date : September 1, 2018

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 Name: Leukomed Sorbact

No Intervention: Non-DACC coated Occlusive Post-operative Film Dressing
Non-DACC coated Occlusive Post-operative Film Dressing



Primary Outcome Measures :
  1. 30 day infection rate [ Time Frame: 30 days ]
    Surgical Site Infection at 30 days post-op


Secondary Outcome Measures :
  1. 1 year infection rate [ Time Frame: 1 year ]
    Surgical Site Infection at 1 year post-op (implant patients only)

  2. Quality of Life (SF-36 V2) [ Time Frame: 7 days, 30 days, 3 months, 6 months, 1 year ]
  3. Quality of Life (EQ-5D-5L) [ Time Frame: 7 days, 30 days, 3 months, 6 months, 1 year ]
  4. Mortality [ Time Frame: 30 days ]
    30-day mortality



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 vascular surgery who are able to consent to the trial.
  • Able to understand the Patient Information Sheet and capable and willing to give informed consent and follow the protocol requirements (including attending all follow-up visits)

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 carotid endarterectomy.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02992951


Locations
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United Kingdom
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
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Principal Investigator: George Smith, M.D Hull and East Yorkshire NHS Trust
Additional Information:
Publications:
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Responsible Party: Hull University Teaching Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT02992951    
Other Study ID Numbers: R2034
First Posted: December 14, 2016    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Infection
Surgical Site Infection
Dialkylcarbamoylchloride
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Surgical Wound Infection
Wound Infection
Bacterial Infections
Wounds and Injuries
Surgical Wound
Postoperative Complications
Pathologic Processes