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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05773781

Acronym

PuraBond PROOF

Enrollment

Registered

2023-03-17

Start date

2023-10-16

Completion date

2024-08-30

Last updated

2025-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemorrhage, Hemostatics, Oral Cavity, Oropharynx, Pain

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.

Interventions

OTHERPuraBond

Application of PuraBond to surgical field

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in Pain on the Visual Analogue Scale (VAS) at Day 30	Baseline and day 30	Visual Analogue Scale (VAS) score from 0 (no pain) to 10 (worst pain)
Change From Baseline in Pain on the Visual Analogue Scale (VAS) at Day 14	Baseline and day 14	Visual Analogue Scale (VAS) score from 0 (no pain) to 10 (worst pain)
Change From Baseline in Cumulative Pain on the Visual Analogue Scale (VAS) at Postoperative Week 1	Baseline and day 7	Visual Analogue Scale (VAS) score from 0 (no pain) to 10 (worst pain)
Change From Baseline in Cumulative Pain on the Visual Analogue Scale (VAS) at Postoperative Week 2	Baseline and day 14	Visual Analogue Scale (VAS) score from 0 (no pain) to 10 (worst pain)
Change From Baseline in Cumulative Pain on the Visual Analogue Scale (VAS) at Postoperative Day 30	Baseline and day 30	Visual Analogue Scale (VAS) score from 0 (no pain) to 10 (worst pain)
Change From Baseline in Pain on the Visual Analogue Scale (VAS) at Day 1	Baseline and day 1	Visual Analogue Scale (VAS) score from 0 (no pain) to 10 (worst pain)
Change From Baseline in Pain on the Visual Analogue Scale (VAS) at Day 2	Baseline and day 2	Visual Analogue Scale (VAS) score from 0 (no pain) to 10 (worst pain)
Change From Baseline in Pain on the Visual Analogue Scale (VAS) at Day 4	Baseline and day 4	Visual Analogue Scale (VAS) score from 0 (no pain) to 10 (worst pain)
Change From Baseline in Pain on the Visual Analogue Scale (VAS) at Day 7	Baseline and day 7	Visual Analogue Scale (VAS) score from 0 (no pain) to 10 (worst pain)

Secondary

Measure	Time frame	Description
Secondary Return to Theatre	Day 1 to day 30 postoperatively	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
Readmission	Within 30 days post operatively	Number of patients requiring hospital readmission
Primary Haemorrhage	Within 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

Countries

United Kingdom

Participant flow

Participants by arm

Arm	Count
PuraBond® Surgery with PuraBond® application to surgical field.	32
No PuraBond® Surgery without PuraBond® application to surgical field.	36
Total	68

Baseline characteristics

Characteristic	No PuraBond®	Total	PuraBond®
Age, Continuous	64 years	64 years	64 years
Primary tumour site Oral cavity	12 Participants	21 Participants	9 Participants
Primary tumour site Oropharynx	24 Participants	47 Participants	23 Participants
Race and Ethnicity Not Collected	—	0 Participants	—
Region of Enrollment United Kingdom	36 participants	68 participants	32 participants
Sex: Female, Male Female	11 Participants	17 Participants	6 Participants
Sex: Female, Male Male	25 Participants	51 Participants	26 Participants
Smoking status Current	3 Participants	9 Participants	6 Participants
Smoking status Ex-smoker	12 Participants	24 Participants	12 Participants
Smoking status Never	21 Participants	35 Participants	14 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 32	0 / 36
other Total, other adverse events	6 / 32	7 / 36
serious Total, serious adverse events	1 / 32	3 / 36