Clinical trial NCT05773781: PuraBond® and Pain Following Resection of Oral or Oropharyngeal Mucosal Lesions
Official title: A Randomised Controlled Trial Investigating the Use of PuraBond® (3-D Matrix) in Transoral Resections of Primary Oral or Oropharyngeal Mucosal Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Hemorrhage
Hemostatics
Oropharynx
Oral Cavity
Lead sponsor: University of Liverpool
Sponsor class: OTHER
First posted: 2023-03-17
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain
timeFrame: Change from baseline pre-operative VAS pain score at days 1, 2, 4, 7, 14 and 30 post operatively
Secondary outcomes:
measure: Readmission
timeFrame: Within 30 days post operatively
measure: Primary haemorrhage
timeFrame: 24 hours post operatively
measure: Secondary haemorrhage
timeFrame: Day 1 to day 30 post operatively
measure: LOS
timeFrame: Within 30 days post operatively
measure: Primary return to theatre
timeFrame: 24 hours post operatively
measure: Secondary return to theatre
timeFrame: Day 1 to day 30 post operatively
measure: Oral feeding
timeFrame: Within 30 days post operatively
measure: Analgesia use
timeFrame: Within 30 days post operatively
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Liverpool University Hospitals Foundation Trust (LUHFT)
Study officials:
References: