Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05773781
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2023-03-02
Brief Title:
PuraBond and Pain Following Resection of Oral or Oropharyngeal Mucosal Lesions
Sponsor:
University of Liverpool
Organization:
University of Liverpool
Study Overview
Official Title:
A Randomised Controlled Trial Investigating the Use of PuraBond 3-D Matrix in Transoral Resections of Primary Oral or Oropharyngeal Mucosal Lesions
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PuraBond PROOF
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None