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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Hemorrhage; Oral Cavity; Hemostatics; Oropharynx
• Intervention / Treatment: Other: PuraBond

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Liverpool, United Kingdom, L9 7AL
    • Liverpool University Hospitals Foundation Trust (LUHFT)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient and disease factors are deemed suitable for transoral surgery under general anaesthetic.
• Decision to treat with primary transoral resection or local excision biopsy.
• Written informed consent provided.
• Clinically suspected or histologically confirmed primary dysplasia or malignancy of the oral cavity or oropharynx OR histologically confirmed diagnosis of squamous cell carcinoma in a cervical lymph node of unknown primary.
• Patient considered fit for surgery.

Exclusion Criteria:

• Lesions undergoing incisional or punch biopsy only.
• Surgery with planned primary closure or local/ distant flap reconstruction.
• Inability to provide written informed consent.
• Medical contraindication to a general anaesthetic or to PuraBond® use.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PuraBond®; Surgery with PuraBond® application to surgical field.	Other: PuraBond; Application of PuraBond to surgical field
No Intervention: No PuraBond®; Surgery without PuraBond® application to surgical field.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Cumulative Pain on the Visual Analogue Scale (VAS) at Postoperative Week 1	Visual Analogue Scale (VAS) score from 0 (no pain) to 10 (worst pain)	Baseline and day 7
Change From Baseline in Cumulative Pain on the Visual Analogue Scale (VAS) at Postoperative Week 2	Visual Analogue Scale (VAS) score from 0 (no pain) to 10 (worst pain)	Baseline and day 14
Change From Baseline in Cumulative Pain on the Visual Analogue Scale (VAS) at Postoperative Day 30	Visual Analogue Scale (VAS) score from 0 (no pain) to 10 (worst pain)	Baseline and day 30
Change From Baseline in Pain on the Visual Analogue Scale (VAS) at Day 1	Visual Analogue Scale (VAS) score from 0 (no pain) to 10 (worst pain)	Baseline and day 1
Change From Baseline in Pain on the Visual Analogue Scale (VAS) at Day 2	Visual Analogue Scale (VAS) score from 0 (no pain) to 10 (worst pain)	Baseline and day 2
Change From Baseline in Pain on the Visual Analogue Scale (VAS) at Day 4	Visual Analogue Scale (VAS) score from 0 (no pain) to 10 (worst pain)	Baseline and day 4
Change From Baseline in Pain on the Visual Analogue Scale (VAS) at Day 7	Visual Analogue Scale (VAS) score from 0 (no pain) to 10 (worst pain)	Baseline and day 7
Change From Baseline in Pain on the Visual Analogue Scale (VAS) at Day 14	Visual Analogue Scale (VAS) score from 0 (no pain) to 10 (worst pain)	Baseline and day 14
Change From Baseline in Pain on the Visual Analogue Scale (VAS) at Day 30	Visual Analogue Scale (VAS) score from 0 (no pain) to 10 (worst pain)	Baseline and day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Readmission	Number of patients requiring hospital readmission	Within 30 days post operatively
LOS	Length of stay in hospital	Within 30 days post operatively
Primary Haemorrhage	Number of patients with primary haemorrhage	Within 24 hours post operatively
Secondary Haemorrhage	Number of patients with secondary haemorrhage	Day 1 to day 30 post operatively
Primary Return to Theatre	Number of patients requiring return to operating room	24 hours post operatively
Secondary Return to Theatre	Number of patients requiring return to operating room	Day 1 to day 30 postoperatively
Oral Feeding	Time taken to normal dietary intake	Within 30 days post operatively
Analgesia Use	Drug, dose, route and frequency of post-operative analgesia usage	Within 30 days post operatively

Collaborators and Investigators

• Sponsor: University of Liverpool

Publications and helpful links

General Publications

• Ghazal Asswad R, Constable J, Abdelrahman A, Banks P, Mellor Z, Jones TM, Shaw R, Davies K, Loh C, Jackson R, Schache A, Fleming JC. The effect of PuraBond(R) on postoperative pain following transoral resections of primary oral or oropharyngeal neoplastic mucosal lesions: A blinded randomised controlled study (PuraBond(R) PROOF). Eur J Surg Oncol. 2025 Jul 11;51(10):110322. doi: 10.1016/j.ejso.2025.110322. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2023
• Primary Completion (Actual): August 30, 2024
• Study Completion (Actual): August 30, 2024

Study Registration Dates

• First Submitted: March 2, 2023
• First Submitted That Met QC Criteria: March 15, 2023
• First Posted (Actual): March 17, 2023

Study Record Updates

• Last Update Posted (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: August 27, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Hemorrhage
• Other Study ID Numbers: UoL001737

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No