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

NCT05773781 | Completed Results

• 1 other identifier: UoL001737
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain; Hemorrhage; Hemostatics; Oropharynx; Oral Cavity

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (8)

• Readmission

  Within 30 days post operatively

• Primary Haemorrhage

  Within 24 hours post operatively

• Secondary Haemorrhage

  Day 1 to day 30 post operatively

• LOS

  Within 30 days post operatively

• Primary Return to Theatre

  24 hours post operatively

Study Arms (2)

PuraBond®

ACTIVE COMPARATOR

Surgery with PuraBond® application to surgical field.

Other: PuraBond

No PuraBond®

NO INTERVENTION

Surgery without PuraBond® application to surgical field.

Interventions

PuraBond OTHER

Application of PuraBond to surgical field

PuraBond®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Liverpool: lead

Study Sites (1)

Liverpool University Hospitals Foundation Trust (LUHFT)

Liverpool, L9 7AL, United Kingdom

Location

Related Publications (1)

• 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 Oct;51(10):110322. doi: 10.1016/j.ejso.2025.110322. Epub 2025 Jul 11.

  PMID: 40669355 DERIVED

MeSH Terms

Conditions

Pain; Hemorrhage

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Results Point of Contact

• Title: Mr Jason Fleming
• Organization: University of Liverpool

Jason.Fleming@liverpool.ac.uk

0151 529 5259

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: March 17, 2023
• Study Start: October 16, 2023
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: September 16, 2025
• Results First Posted: September 16, 2025

Record last verified: 2024-11

Locations

GB (1)