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PainPuraBond PROOFNCT05773781

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

A study testing PuraBond in people with Pain and Hemorrhage, run by University of Liverpool at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain, Hemorrhage, Hemostatics
What is being tested?
PuraBond
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
1 siteUnited Kingdom
Study dates
16 Oct 2023to 30 Aug 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Liverpool University Hospitals Foundation Trust (LUHFT)

    Liverpool, L9 7AL

Other trials in United Kingdom

About this study

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

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.

Read the 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.

Being tested
PuraBond
Medical subject headings
Pain, Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PuraBondOther

    Application of PuraBond to surgical field

Study groups in NCT05773781
Study groupRoleWhat they receive
PuraBond®Active comparatorSurgery with PuraBond® application to surgical field.
Receives: Other: PuraBond
No PuraBond®No interventionSurgery without PuraBond® application to surgical field.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Baseline and day 7

  2. 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)

    Measured: Baseline and day 14

  3. 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)

    Measured: Baseline and day 30

  4. 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)

    Measured: Baseline and day 1

  5. 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)

    Measured: Baseline and day 2

  6. 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)

    Measured: Baseline and day 4

  7. 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)

    Measured: Baseline and day 7

  8. 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)

    Measured: Baseline and day 14

  9. 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)

    Measured: Baseline and day 30

Secondary outcomes (8)

  1. Readmission

    Number of patients requiring hospital readmission

    Measured: Within 30 days post operatively

  2. Primary Haemorrhage

    Number of patients with primary haemorrhage

    Measured: Within 24 hours post operatively

  3. Secondary Haemorrhage

    Number of patients with secondary haemorrhage

    Measured: Day 1 to day 30 post operatively

  4. LOS

    Length of stay in hospital

    Measured: Within 30 days post operatively

  5. Primary Return to Theatre

    Number of patients requiring return to operating room

    Measured: 24 hours post operatively

  6. Secondary Return to Theatre

    Number of patients requiring return to operating room

    Measured: Day 1 to day 30 postoperatively

  7. Oral Feeding

    Time taken to normal dietary intake

    Measured: Within 30 days post operatively

  8. Analgesia Use

    Drug, dose, route and frequency of post-operative analgesia usage

    Measured: Within 30 days post operatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2023
  2. Study start16 Oct 2023
  3. Primary completion30 Aug 2024
  4. Study completion30 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05773781
Sponsor's protocol ID
UoL001737
Acronym
PuraBond PROOF
Status last verified
Nov 2024
First submitted
2 Mar 2023
Last updated
16 Sep 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 40669355

Questions about this trial

What is this clinical trial studying?

A study testing PuraBond in people with Pain and Hemorrhage, run by University of Liverpool at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Cumulative Pain on the Visual Analogue Scale (VAS) at Postoperative Week 1 (time frame: Baseline and day 7). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05773781, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.

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