Examination of clinical performance of debridement pad
Research type
Research Study
Full title
Post market clinical follow up study to examine clinical performance of the debridement pad Cutimed DebriClean
IRAS ID
289658
Contact name
Leanne Atkin
Contact email
Sponsor organisation
BSN medical GmbH Essity
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
NIHR Clinical Research Network (CRN) Portfolio, DERM 47103 and Protocol Ref: C2533
Duration of Study in the UK
0 years, 5 months, 23 days
Research summary
To improve the conditions for wound healing, it is essential to remove devitalised tissue, dysfunctional cells, biofilm (bacteria) or slough (wound debris) with so called debridement. Debridement encourages the formation of healthy granulation tissue in the wound bed. Regularly wound debridement is seen as good clinical practice.
There are several methods of debridement available, including surgical, autolytic (wound dressings), biological (maggots) and mechanical debridement. The choice of the optimal debridement method depends on several factors including wound characteristics, patients´ comorbidities, and clinical history, pain threshold, the availability of clinical resources, and the skills of the wound care givers. Out of the mentioned debridement options, mechanical debridement is the fastest method and requires no special expertise/training to use.
Mechanical debridement using debridement pads is common practice across the UK, there are several debridement pads on the market. One of these is Cutimed DebriClean, the product under investigation.
Cutimed DebriClean is a sterile, single-use device which contains white and blue mono-filament microfiber loops which safely and effectively removed wound debris. It looks like a simple pad and is used as a wipe on the wound bed/surrounding skin, it is not left in place like a wound dressing.
Cutimed DebriClean is a CE-marked medical device and will be used within the scope of its
intended purpose. As part of the Medical Device Regulation (MDR, Council Regulation 2017/745) there is a requirement for Post Market Clinical Follow up (PMCF) to proactively collect and evaluate clinical data from the use of the product. This study intents to use Cutimed DebriClean as the choice of debridement pad whilst undertaking routine wound debridement within a hospital clinic setting with the aim of ensuring the safety and performance of the device.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
20/EM/0291
Date of REC Opinion
5 Jan 2021
REC opinion
Further Information Favourable Opinion