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

Pain Clinical Trial

— PuraBond PROOF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05773781
• Other study ID #: UoL001737
• Status: Recruiting
• Phase: N/A
• Start date: October 16, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2024
• Source: University of Liverpool
• Contact: Jason Fleming, FRCS(ORL-HNS) MEd PhD
• Phone: 0151 529 5259
• Email: Jason.fleming[@]liverpool.ac.uk
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhage
• Oral Cavity
• Oropharynx
• Pain

Intervention

Other:
• PuraBond
Application of PuraBond to surgical field

Locations

Country	Name	City	State
United Kingdom	Liverpool University Hospitals Foundation Trust (LUHFT)	Liverpool

Sponsors (1)

Lead Sponsor	Collaborator
University of Liverpool

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	Visual Analogue Scale (VAS) score from 1-10	Change from baseline pre-operative VAS pain score at days 1, 2, 4, 7, 14 and 30 post operatively
Secondary	Readmission	Number of patients requiring hospital readmission	Within 30 days post operatively
Secondary	Primary haemorrhage	Number of patients with primary haemorrhage	24 hours post operatively
Secondary	Secondary haemorrhage	Number of patients with secondary haemorrhage	Day 1 to day 30 post operatively
Secondary	LOS	Length of stay in hospital	Within 30 days post operatively
Secondary	Primary return to theatre	Number of patients requiring return to operating room	24 hours post operatively
Secondary	Secondary return to theatre	Number of patients requiring return to operating room	Day 1 to day 30 post operatively
Secondary	Oral feeding	Time taken to normal dietary intake	Within 30 days post operatively
Secondary	Analgesia use	Drug, dose, route and frequency of post-operative analgesia usage	Within 30 days post operatively