N/A
N=73
PuraBond® and Pain Following Resection of Oral or Oropharyngeal Mucosal Lesions
Pain · Hemorrhage · Hemostatics · Oropharynx · Oral Cavity
Bottom Line
View on ClinicalTrials.gov: NCT05773781 ↗Enrolled (actual)
73
Serious AEs
5.9%
Results posted
Sep 2025
Primary outcome: Primary: Change From Baseline in Cumulative Pain on the Visual Analogue Scale (VAS) at Postoperative Week 1 — 3.27; 4.35 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PuraBond (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Liverpool
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Cumulative Pain on the Visual Analogue Scale (VAS) at Postoperative Week 1 |
3.27; 4.35 | — |
| PRIMARY Change From Baseline in Cumulative Pain on the Visual Analogue Scale (VAS) at Postoperative Week 2 |
2.95; 3.91 | — |
| PRIMARY Change From Baseline in Cumulative Pain on the Visual Analogue Scale (VAS) at Postoperative Day 30 |
2.56; 3.41 | — |
| PRIMARY Change From Baseline in Pain on the Visual Analogue Scale (VAS) at Day 1 |
2.46; 3.30 | — |
| PRIMARY Change From Baseline in Pain on the Visual Analogue Scale (VAS) at Day 2 |
2.98; 3.87 | — |
| PRIMARY Change From Baseline in Pain on the Visual Analogue Scale (VAS) at Day 4 |
3.36; 4.06 | — |
| PRIMARY Change From Baseline in Pain on the Visual Analogue Scale (VAS) at Day 7 |
3.15; 4.28 | — |
| PRIMARY Change From Baseline in Pain on the Visual Analogue Scale (VAS) at Day 14 |
1.38; 1.66 | — |
| PRIMARY Change From Baseline in Pain on the Visual Analogue Scale (VAS) at Day 30 |
0.23; 0.26 | — |
| SECONDARY Readmission |
— | — |
| SECONDARY Primary Haemorrhage |
0; 0 | — |
| SECONDARY Secondary Haemorrhage |
2; 6 | — |
| SECONDARY LOS |
— | — |
| SECONDARY Primary Return to Theatre |
0; 0 | — |
| SECONDARY Secondary Return to Theatre |
1; 1 | — |
| SECONDARY Oral Feeding |
— | — |
| SECONDARY Analgesia Use |
— | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT05773781). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.