PuraBond PROOF: PuraBond® and Pain Following Resection of Oral or Oropharyngeal Mucosal Lesions
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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. |
Outcome Measures
Primary Outcome Measures
- Pain [Change from baseline pre-operative VAS pain score at days 1, 2, 4, 7, 14 and 30 post operatively]
Continuous pain Visual Analogue Scale (VAS) score from 1-10 (10 representing worst pain)
Secondary Outcome Measures
- Readmission [Within 30 days post operatively]
Number of patients requiring hospital readmission
- Primary haemorrhage [24 hours post operatively]
Number of patients with primary haemorrhage
- Secondary haemorrhage [Day 1 to day 30 post operatively]
Number of patients with secondary haemorrhage
- LOS [Within 30 days post operatively]
Length of stay in hospital
- Primary return to theatre [24 hours post operatively]
Number of patients requiring return to operating room
- Secondary return to theatre [Day 1 to day 30 post operatively]
Number of patients requiring return to operating room
- Oral feeding [Within 30 days post operatively]
Time taken to normal dietary intake
- Analgesia use [Within 30 days post operatively]
Drug, dose, route and frequency of post-operative analgesia usage
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient and disease factors are deemed suitable for transoral surgery under general anaesthetic.
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Decision to treat with primary transoral resection or local excision biopsy.
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Written informed consent provided.
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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.
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Patient considered fit for surgery.
Exclusion Criteria:
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Lesions undergoing incisional or punch biopsy only.
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Surgery with planned primary closure or local/ distant flap reconstruction.
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Inability to provide written informed consent.
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Medical contraindication to a general anaesthetic or to PuraBond® use.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Liverpool University Hospitals Foundation Trust (LUHFT) | Liverpool | United Kingdom | L9 7AL |
Sponsors and Collaborators
- University of Liverpool
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UoL001737