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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05773781
Other study ID # UoL001737
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 16, 2023
Est. completion date June 30, 2024

Study information

Verified date May 2024
Source University of Liverpool
Contact Jason Fleming, FRCS(ORL-HNS) MEd PhD
Phone 0151 529 5259
Email Jason.fleming@liverpool.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 64
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
PuraBond
Application of PuraBond to surgical field

Locations

Country Name City State
United Kingdom Liverpool University Hospitals Foundation Trust (LUHFT) Liverpool

Sponsors (1)

Lead Sponsor Collaborator
University of Liverpool

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Visual Analogue Scale (VAS) score from 1-10 Change from baseline pre-operative VAS pain score at days 1, 2, 4, 7, 14 and 30 post operatively
Secondary Readmission Number of patients requiring hospital readmission Within 30 days post operatively
Secondary Primary haemorrhage Number of patients with primary haemorrhage 24 hours post operatively
Secondary Secondary haemorrhage Number of patients with secondary haemorrhage Day 1 to day 30 post operatively
Secondary LOS Length of stay in hospital Within 30 days post operatively
Secondary Primary return to theatre Number of patients requiring return to operating room 24 hours post operatively
Secondary Secondary return to theatre Number of patients requiring return to operating room Day 1 to day 30 post operatively
Secondary Oral feeding Time taken to normal dietary intake Within 30 days post operatively
Secondary Analgesia use Drug, dose, route and frequency of post-operative analgesia usage Within 30 days post operatively
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