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

NCT ID: NCT05773781

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-16
• Study Completion Date: 2024-08-30

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.

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.

Conditions

Pain; Hemorrhage; Hemostatics; Oropharynx; Oral Cavity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

PuraBond®

Surgery with PuraBond® application to surgical field.

Group Type: ACTIVE_COMPARATOR

PuraBond

Intervention Type: OTHER

Application of PuraBond to surgical field

No PuraBond®

Surgery without PuraBond® application to surgical field.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

PuraBond

Application of PuraBond to surgical field

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Liverpool

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Liverpool University Hospitals Foundation Trust (LUHFT)

Liverpool, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 40669355 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

UoL001737

Identifier Type: -

Identifier Source: org_study_id