RADA16 for Reducing Drain Output Trajectory Following Neck Dissection

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorSt. James's Hospital, Ireland

About this trial

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 occurrence of seroma, a complication related to but distinct from haematoma, following neck dissection surgery. Patients undergoing neck dissection surgery will be randomised either to standard post-operative care following neck dissection or to standard post-operative care and Purabond. Drains are placed routinely following surgery of this type and their removal is dictated by the volume of fluid produced per day - it is hypothesised that Purabond will reduce the volume of fluid produced and thereby facilitate earlier drain removal.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Patients unable to satisfy all the above listed inclusion criteria.

Trial design

Treatments tested in this trial

  • Purabond

Treatment groups

208 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

St. James's Hospital, Ireland

Lead sponsor

Royal College of Surgeons, Ireland

Collaborator