PuraBond® and Pain Following Resection of Oral or Oropharyngeal Mucosal Lesions
- Conditions
- OropharynxOral CavityHemorrhagePainHemostatics
- Interventions
- Other: PuraBond
- Registration Number
- NCT05773781
- Lead Sponsor
- University of Liverpool
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 73
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PuraBond® PuraBond Surgery with PuraBond® application to surgical field.
- Primary Outcome Measures
Name Time Method Pain Change from baseline pre-operative VAS pain score at days 1, 2, 4, 7, 14 and 30 post operatively Visual Analogue Scale (VAS) score from 1-10
- Secondary Outcome Measures
Name Time Method Primary haemorrhage 24 hours post operatively Number of patients with primary haemorrhage
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
Readmission Within 30 days post operatively Number of patients requiring hospital readmission
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 haemorrhage Day 1 to day 30 post operatively Number of patients with secondary haemorrhage
Analgesia use Within 30 days post operatively Drug, dose, route and frequency of post-operative analgesia usage
Trial Locations
- Locations (1)
Liverpool University Hospitals Foundation Trust (LUHFT)
🇬🇧Liverpool, United Kingdom