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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain, Hemorrhage, Hemostatics, Oropharynx, Oral Cavity

Intervention / Treatment
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* Other: PuraBond


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PuraBond®<br>Surgery with PuraBond® application to surgical field. | Other: PuraBond<br>* Application of PuraBond to surgical field<br>|
| No Intervention: No PuraBond®<br>Surgery without PuraBond® application to surgical field. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Continuous pain Visual Analogue Scale (VAS) score from 1-10 (10 representing worst pain) | Change from baseline pre-operative VAS pain score at days 1, 2, 4, 7, 14 and 30 post operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readmission | Number of patients requiring hospital readmission | Within 30 days post operatively | 
| Primary haemorrhage | Number of patients with primary haemorrhage | 24 hours post operatively | 
| Secondary haemorrhage | Number of patients with secondary haemorrhage | Day 1 to day 30 post operatively | 
| LOS | Length of stay in hospital | Within 30 days 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 post operatively | 
| 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 |