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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PuraBond® | Active Comparator | Surgery with PuraBond® application to surgical field. |
|
| No PuraBond® | No Intervention | Surgery without PuraBond® application to surgical field. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PuraBond | Other | Application of PuraBond to surgical field |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Cumulative Pain on the Visual Analogue Scale (VAS) at Postoperative Week 1 | Visual Analogue Scale (VAS) score from 0 (no pain) to 10 (worst pain) | Baseline and day 7 |
| Change From Baseline in Cumulative Pain on the Visual Analogue Scale (VAS) at Postoperative Week 2 | Visual Analogue Scale (VAS) score from 0 (no pain) to 10 (worst pain) | Baseline and day 14 |
| Change From Baseline in Cumulative Pain on the Visual Analogue Scale (VAS) at Postoperative Day 30 | Visual Analogue Scale (VAS) score from 0 (no pain) to 10 (worst pain) | Baseline and day 30 |
| Change From Baseline in Pain on the Visual Analogue Scale (VAS) at Day 1 | Visual Analogue Scale (VAS) score from 0 (no pain) to 10 (worst pain) | Baseline and day 1 |
| Change From Baseline in Pain on the Visual Analogue Scale (VAS) at Day 2 | Visual Analogue Scale (VAS) score from 0 (no pain) to 10 (worst pain) | Baseline and day 2 |
| Change From Baseline in Pain on the Visual Analogue Scale (VAS) at Day 4 | Visual Analogue Scale (VAS) score from 0 (no pain) to 10 (worst pain) | Baseline and day 4 |
| Change From Baseline in Pain on the Visual Analogue Scale (VAS) at Day 7 | Visual Analogue Scale (VAS) score from 0 (no pain) to 10 (worst pain) |
| Measure | Description | Time Frame |
|---|---|---|
| Readmission | Number of patients requiring hospital readmission | Within 30 days post operatively |
| Primary Haemorrhage | Number of patients with primary haemorrhage |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liverpool University Hospitals Foundation Trust (LUHFT) | Liverpool | L9 7AL | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40669355 | Derived | Ghazal Asswad R, Constable J, Abdelrahman A, Banks P, Mellor Z, Jones TM, Shaw R, Davies K, Loh C, Jackson R, Schache A, Fleming JC. The effect of PuraBond(R) on postoperative pain following transoral resections of primary oral or oropharyngeal neoplastic mucosal lesions: A blinded randomised controlled study (PuraBond(R) PROOF). Eur J Surg Oncol. 2025 Oct;51(10):110322. doi: 10.1016/j.ejso.2025.110322. Epub 2025 Jul 11. |
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| ID | Title | Description |
|---|---|---|
| FG000 | PuraBond® | Surgery with PuraBond® application to surgical field. |
| FG001 | No PuraBond® | Surgery without PuraBond® application to surgical field. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PuraBond® | Surgery with PuraBond® application to surgical field. |
| BG001 | No PuraBond® | Surgery without PuraBond® application to surgical field. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Cumulative Pain on the Visual Analogue Scale (VAS) at Postoperative Week 1 | Visual Analogue Scale (VAS) score from 0 (no pain) to 10 (worst pain) | Posted | Mean | Standard Deviation | score on a scale | Baseline and day 7 |
|
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PuraBond® | Surgery with PuraBond® application to surgical field. | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemorrhage | Surgical and medical procedures | Systematic Assessment | Haemorrhage requiring return to theatre for arrest of bleeding. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mr Jason Fleming | University of Liverpool | 0151 529 5259 | Jason.Fleming@liverpool.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 26, 2023 | Aug 17, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
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| Baseline and day 7 |
| Change From Baseline in Pain on the Visual Analogue Scale (VAS) at Day 14 | Visual Analogue Scale (VAS) score from 0 (no pain) to 10 (worst pain) | Baseline and day 14 |
| Change From Baseline in Pain on the Visual Analogue Scale (VAS) at Day 30 | Visual Analogue Scale (VAS) score from 0 (no pain) to 10 (worst pain) | Baseline and day 30 |
| Within 24 hours post operatively |
| Secondary Haemorrhage | Number of patients with secondary haemorrhage | Day 1 to day 30 post operatively |
| LOS | Length of stay in hospital | Within 30 days post operatively |
| Primary Return to Theatre | Number of patients requiring return to operating room | 24 hours post operatively |
| Secondary Return to Theatre | Number of patients requiring return to operating room | Day 1 to day 30 postoperatively |
| Oral Feeding | Time taken to normal dietary intake | Within 30 days post operatively |
| Analgesia Use | Drug, dose, route and frequency of post-operative analgesia usage | Within 30 days post operatively |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Smoking status | Count of Participants | Participants |
|
| Primary tumour site | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | Change From Baseline in Cumulative Pain on the Visual Analogue Scale (VAS) at Postoperative Week 2 | Visual Analogue Scale (VAS) score from 0 (no pain) to 10 (worst pain) | Posted | Mean | Standard Deviation | score on a scale | Baseline and day 14 |
|
|
|
| Primary | Change From Baseline in Cumulative Pain on the Visual Analogue Scale (VAS) at Postoperative Day 30 | Visual Analogue Scale (VAS) score from 0 (no pain) to 10 (worst pain) | Posted | Mean | Standard Deviation | score on a scale | Baseline and day 30 |
|
|
|
| Primary | Change From Baseline in Pain on the Visual Analogue Scale (VAS) at Day 1 | Visual Analogue Scale (VAS) score from 0 (no pain) to 10 (worst pain) | Posted | Mean | Standard Deviation | score on a scale | Baseline and day 1 |
|
|
|
| Primary | Change From Baseline in Pain on the Visual Analogue Scale (VAS) at Day 2 | Visual Analogue Scale (VAS) score from 0 (no pain) to 10 (worst pain) | Posted | Mean | Standard Deviation | score on a scale | Baseline and day 2 |
|
|
|
| Primary | Change From Baseline in Pain on the Visual Analogue Scale (VAS) at Day 4 | Visual Analogue Scale (VAS) score from 0 (no pain) to 10 (worst pain) | Posted | Mean | Standard Deviation | score on a scale | Baseline and day 4 |
|
|
|
| Primary | Change From Baseline in Pain on the Visual Analogue Scale (VAS) at Day 7 | Visual Analogue Scale (VAS) score from 0 (no pain) to 10 (worst pain) | Posted | Mean | Standard Deviation | score on a scale | Baseline and day 7 |
|
|
|
| Primary | Change From Baseline in Pain on the Visual Analogue Scale (VAS) at Day 14 | Visual Analogue Scale (VAS) score from 0 (no pain) to 10 (worst pain) | Posted | Mean | Standard Deviation | score on a scale | Baseline and day 14 |
|
|
|
| Primary | Change From Baseline in Pain on the Visual Analogue Scale (VAS) at Day 30 | Visual Analogue Scale (VAS) score from 0 (no pain) to 10 (worst pain) | Posted | Mean | Standard Deviation | score on a scale | Baseline and day 30 |
|
|
|
| Secondary | Readmission | Number of patients requiring hospital readmission | Not Posted | Within 30 days post operatively | Participants |
| Secondary | Primary Haemorrhage | Number of patients with primary haemorrhage | Posted | Count of Participants | Participants | Within 24 hours post operatively |
|
|
|
| Secondary | Secondary Haemorrhage | Number of patients with secondary haemorrhage | Posted | Count of Participants | Participants | Day 1 to day 30 post operatively |
|
|
|
| Secondary | LOS | Length of stay in hospital | Not Posted | Within 30 days post operatively | Participants |
| Secondary | Primary Return to Theatre | Number of patients requiring return to operating room | Posted | Count of Participants | Participants | 24 hours post operatively |
|
|
|
| Secondary | Secondary Return to Theatre | Number of patients requiring return to operating room | Posted | Count of Participants | Participants | Day 1 to day 30 postoperatively |
|
|
|
| Secondary | Oral Feeding | Time taken to normal dietary intake | Not Posted | Within 30 days post operatively | Participants |
| Secondary | Analgesia Use | Drug, dose, route and frequency of post-operative analgesia usage | Not Posted | Within 30 days post operatively | Participants |
| 32 |
| 1 |
| 32 |
| 6 |
| 32 |
| EG001 | No PuraBond® | Surgery without PuraBond® application to surgical field. | 0 | 36 | 3 | 36 | 7 | 36 |
|
| Haemorrhage | Surgical and medical procedures | Systematic Assessment | Haemorrhage requiring hospital readmission. |
|
| Cerebral infarct | Vascular disorders | Systematic Assessment |
|
| Wound infection | Infections and infestations | Systematic Assessment |
|
| Chest infection | Infections and infestations | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | Systematic Assessment |
|
| First bite syndrome | Injury, poisoning and procedural complications | Systematic Assessment |
|
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| Current |
|