PuraBond® and Pain Following Resection of Oral or Oropharyngeal Mucosal Lesions (NCT05773781) | Clinical Trial Compass
CompletedNot Applicable
PuraBond® and Pain Following Resection of Oral or Oropharyngeal Mucosal Lesions
United Kingdom73 participantsStarted 2023-10-16
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in Cumulative Pain on the Visual Analogue Scale (VAS) at Postoperative Week 1
Timeframe: Baseline and day 7
2
Change From Baseline in Cumulative Pain on the Visual Analogue Scale (VAS) at Postoperative Week 2
Timeframe: Baseline and day 14
3
Change From Baseline in Cumulative Pain on the Visual Analogue Scale (VAS) at Postoperative Day 30
Timeframe: Baseline and day 30
4
Change From Baseline in Pain on the Visual Analogue Scale (VAS) at Day 1
Timeframe: Baseline and day 1
5
Change From Baseline in Pain on the Visual Analogue Scale (VAS) at Day 2
Timeframe: Baseline and day 2
6
Change From Baseline in Pain on the Visual Analogue Scale (VAS) at Day 4
Timeframe: Baseline and day 4
7
Change From Baseline in Pain on the Visual Analogue Scale (VAS) at Day 7