PuraBond® and Pain Following Resection of Oral or Oropharyngeal Mucosal Lesions — PuraBond PROOF  

Pain Clinical Trial

Official title: A Randomised Controlled Trial Investigating the Use of PuraBond® (3-D Matrix) in Transoral Resections of Primary Oral or Oropharyngeal Mucosal Lesions

Status Recruiting

Clinical Trial Summary

To evaluate the use of Purabond® in transoral resections of primary oral or oropharyngeal lesions for diagnostic and therapeutic procedures. Patients will be enrolled and randomised to either have PuraBond® applied to the surgical field or not intra operatively. The primary outcome measure will assess if this intervention significantly reduces acute pain during the 30 day post-operative period alongside other post-operative complication rates and recovery outcomes.

Clinical Trial Description

PuraBond® PROOF is a prospective, single centre, parallel group randomised controlled trial. Transoral approaches in head and neck surgery have become more common given they offer a minimally invasive approach to surgery, thus removing the need for external incisions in the neck. Post operative pain and bleeding are clinically important factor that directly impact patient recovery. 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 both 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. Patients undergoing a pre-determined set of operations in either the mouth or oropharynx will be randomised to either receive PuraBond® to the surgical field 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 pre and post-operatively by marking their pain level on a continuous scale from 'no pain' to 'the worse possible pain' using the Visual Analogue Scale (VAS). Patients will be enrolled from a single tertiary university hospital trust in the United Kingdom (Liverpool University Hospitals Foundation Trust). Case notes of all patients will also be analysed and data on patient demographics and post operative outcomes collated. This will be the first trial to look at PuraBond® use in head and neck surgery with pain being the primary trial outcome. ;

Related Conditions & MeSH terms

• Hemorrhage
• Oral Cavity
• Oropharynx
• Pain

• NCT number: NCT05773781
• Study type: Interventional
• Source: University of Liverpool
• Contact: Jason Fleming, FRCS(ORL-HNS) MEd PhD
• Phone: 0151 529 5259
• Email: Jason.fleming@liverpool.ac.uk
• Status: Recruiting
• Phase: N/A
• Start date: October 16, 2023
• Completion date: June 30, 2024