Status:
NOT_YET_RECRUITING
RADA16 for Reducing Drain Output Trajectory Following Neck Dissection
Lead Sponsor:
St. James's Hospital, Ireland
Collaborating Sponsors:
Royal College of Surgeons, Ireland
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
This will be a prospective single-blind randomised controlled trial to evaluate if the use of a medical device named Purabond, a haemostatic agent already CE marked for use in Ireland, can reduce the ...
Detailed Description
Purabond is a new medical device taking the form of a gel containing an active ingredient called RADA-16. It is designed to stop bleeding from wounds by forming into a stable barrier (matrix) when com...
Eligibility Criteria
Inclusion
- Patients with head and neck cancer (including thyroid, cutaneous, \& mucosal primaries) for which a neck dissection is indicated as part of treatment.
- Over 18 years of age.
- Able to give informed consent.
Exclusion
- Patients unable to satisfy all the above listed inclusion criteria.
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT06178237
Start Date
March 1 2024
End Date
June 1 2026
Last Update
December 20 2023
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