C3079 - Sorbion RCT - V1.0 28FEB2024
Research type
Research Study
Full title
A prospective, multicenter, partially assessor blinded, randomised, open label, parallel, comparative clinical trial to evaluate the exudate management performance of Cutimed Sorbion product range
IRAS ID
341530
Contact name
Leanne Atkin
Contact email
Sponsor organisation
BSN medical GmbH
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, days
Research summary
Venous leg ulceration is a common type of chronic wound and when non healing adversely impacts patients quality of life. Sufficient management of wound fluid (exudate) is one of the major challenges in wound care as an optimal moist wound environment must be established. Venous leg ulcers are often highly exuding due to several physiological factors. Extensive amounts of fluid must be removed from the wound using appropriate wound dressings. So called superabsorbent dressings are designed to manage moderate to high amounts of exudate to secure the optimal moisture level in the wound bed finally allowing the healing process to start.
Within this trial two different superabsorbent product portfolios will be compared in patients aged ≥ 18 years and suffering from venous leg ulcer indicated to be treated with the study products. As primary objective the dressing´s absorption performance and its ability to prevent skin maceration and leakage of the wound dressing will be investigated. Further, device integrity, need of debridement, wound and skin conditions, treatment related pain, general wound pain, dressing adhesion to wound bed and quality of life as well as HCP´s and patient´s satisfaction are considered as secondary outcomes.
The study will be conducted in wound care centers/wound ambulances in UK, Germany and the US and will last approximately 6 months. During the study patients will be treated with superabsorbent products for approximately 10-14 days (randomly assigned to one of the portfolios) and for a maximum of 30 days.
All study products are CE-marked, sterile, single-use devices intended to maintain moderate to high levels of wound exudate and are an established state-of-the-art dressing category in wound care. They will be used within the scope of their intended purpose. Throughout the study all other standard of care will be continued as deemed necessary by the wound care provider.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
24/YH/0196
Date of REC Opinion
30 Aug 2024
REC opinion
Further Information Favourable Opinion