Challenge Ag 01
Research type
Research Study
Full title
An open-label, randomised, Non-inferiority, multi-centre investigation, with either an infected VLU, DFU or PU to investigate the new Challenge Ag dressing vs Aquacel Ag dressing in terms of efficacy and safety
IRAS ID
197424
Contact name
Joanne McCardle
Contact email
Sponsor organisation
Molnlycke Healthcare AB
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
This study is an open-label, randomised, Non-inferiority, multi-centre investigation. Either an infected Venous Leg Ulcer (VLU), Diabetic Foot Ulcer (DFU) or Pressure Ulcer (PU) to investigate the new Challenge Ag dressing vs Aquacel Ag dressing in terms of efficacy and safety. \n\nThe Challenge Ag dressing is designed to absorb and retain a large amount of exudate. Exudate is the fluid that the body naturally produces in wounds such as ulcers as this plays a vital part for the healing process. It is transformed into a gel that facilitates moist wound healing and helps make the removal of the dressing easier. Silver is released when ChallengeAg comes into contact with exudate and acts as a preservative of the dressing.\n\nThe dressing used will be either the ChallengeAg dressing or AquacelAg Dressing for up to 4 weeks. Exufiber dressing or Aquacel dressing will then be used for an additional 4 weeks. Dressing changes in-between visits are allowed and should be carried out according to clinic routine. A record (dressing log) will be completed for every dressing change. \n\nEach participant will be assessed on a weekly basis for 5 weeks, and again at 6 weeks and 8 weeks. During the assessments, the participant will be asked questions about their ulcer and general health. The participants will be asked to fill in a scale of how they experience pain in relation to the dressing change and will also be asked to complete an evaluation form around how they feel regarding the dressing.\n \nApproximately 15-20 participants will be recruited at each site across clinics in the UK, Belgium and Italy.\nA photograph will be taken of the ulcer immediately after removal of the dressing, before and after cleansing/debridement with saline or warm water if any is required and prior to the application of the new dressing. \n\n
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
16/NW/0391
Date of REC Opinion
20 Jun 2016
REC opinion
Favourable Opinion