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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: ross.lathan2@nhs.net
• Phone: +44 01482674643

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.