A study to compare dressings for venous leg ulcers
Research type
Research Study
Full title
A clinical study to compare the performance of AQUACEL® Ag+ Extra™ and Cutimed® Sorbact® dressing in the management of patients with Venous Leg Ulcers over a 12-week period.
IRAS ID
326566
Contact name
Rosia Shah
Contact email
Sponsor organisation
Convatec Ltd.
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Venous leg ulcers are long-lasting sores that develop on the lower legs. They can develop after minor injuries or due to high pressure in the veins in the legs and are very common in older patients. Most leg ulcers heal within 6 months however if they are incorrectly treated they can take much longer or never heal at all. Bacterial infections cause leg ulcers to heal more slowly as the body produces a defensive response that slows down new cell growth. Bacteria in leg ulcers can form a thin layer over the wound called a biofilm. When bacteria are in a biofilm they are more resistant to antibiotics and delay healing when compared to single-cell bacteria. The current standard of care for treating leg ulcers is removal of dead or infected skin (debridement) followed by a treatment on top of the skin that kills bacteria (topical antimicrobial treatment) followed by another round of debridement.
This study compares two different antimicrobial dressings that can be used to treat venous leg ulcers to see which one works best. Both dressings are currently available and routinely used in clinical practice. One dressing has chemicals that break apart the biofilms once they are formed. One dressing has chemicals that bind to the bacteria so that they can’t form a biofilm. Both dressings reduce the amount of bacteria in the leg ulcer and are used regularly in clinical practice.
Participants who have one wound that is between ≥1 cm2 and ≤100 cm2 that has been present for at least 2 months and <18 months will be eligible to take part. Participants will be treated with one of the two dressings for 4 weeks and will then be managed with Standard of Care for up to 10 weeks or until the wound has healed.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
23/WM/0081
Date of REC Opinion
31 May 2023
REC opinion
Further Information Favourable Opinion