PuraBond PROOF v0.5
Research type
Research Study
Full title
A randomised controlled trial investigating the use of PuraBond® (3-D Matrix) in transoral resections of primary oral or oropharyngeal mucosal lesions
IRAS ID
322447
Contact name
Jason Fleming
Contact email
Sponsor organisation
University of Liverpool
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
PuraBond® PROOF is a non-CTIMP prospective, single centre, parallel group randomised controlled trial. PuraBond® is haemostatic agent, classified as a CE marked class III medical device, that is applied to surgical fields and has been shown to be safe to use and effective in reducing bleeding. This trial will look to investigate the impact of applying PuraBond® in oral cavity or oropharyngeal operations on post-operative pain outcomes. In the PuraBond® PROOF trial, patients undergoing a pre-determined set of operations in either the mouth or oropharynx will be randomised to either receive PuraBond® during the operation or not. This allocation will be random and both treatments are currently used as part of routine standard clinical practice. Participants will be asked to monitor and record their pain levels on days 1, 2, 4, 7, 14 and 30 after their operation by marking their pain level on a continuous scale from ‘no pain’ to ‘the worse possible pain’. This will be the first trial to look at PuraBond® use in head and neck surgery with pain being the primary trial outcome. Secondary outcomes will evaluate post-operative complication rates, recovery outcomes and assess if there is any cost benefit to PuraBond® use.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
23/NW/0056
Date of REC Opinion
7 Mar 2023
REC opinion
Favourable Opinion