Using a special dressing to reduce surgical site infections in vascular surgery

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.

This study is testing a special dressing made from spider silk to see if it can help prevent infections after lower limb vascular surgery compared to regular dressings.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 718 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hull University Teaching Hospitals NHS Trust (other gov)
• Locations: 1 site (Hull, East Riding Of Yorkshire)
• Trial ID: NCT02992951 on ClinicalTrials.gov

What this trial studies

This trial investigates the effectiveness of a DACC-coated dressing, derived from spider silk, in reducing surgical site infections compared to standard non-coated dressings in patients undergoing lower limb vascular surgery. The study will recruit 718 adult patients across multiple centers in the UK, focusing on those with clean or clean-contaminated wounds closed by primary intention. Participants will be monitored for infection rates post-surgery to assess the dressing's performance. The goal is to provide a cost-effective solution to a significant problem in surgical care.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older undergoing clean or clean-contaminated lower limb vascular surgery.

Not a fit: Patients undergoing procedures that do not involve lower limb incisions or those on antibiotics for other conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this dressing could significantly reduce the incidence of surgical site infections, improving patient outcomes and reducing healthcare costs.

How similar studies have performed: While the use of DACC-coated dressings is innovative, similar approaches in infection control have shown promise, suggesting potential for success.

Eligibility 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 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.

Where this trial is running

Hull, East Riding Of Yorkshire

• Academic Vascular Surgery Unit, Vascular Laboratory, Alderson House, Hull Royal Infirmary — Hull, East Riding Of Yorkshire, United Kingdom (RECRUITING)

Study contacts

• Principal investigator: George Smith, M.D — Hull University Teaching Hospitals NHS Trust
• Study coordinator: Ross Lathan, MBChB

Conditions: Infection, Bacterial, Wound Infection, Wound Infection, Surgical, Surgical Incision, Surgical Wound, Infection, Surgical Site Infection, Dialkylcarbamoylchloride