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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Purabond
DeviceApplication of Purabond to surgical field
Treatment groups
Trial outcomes
Primary outcomes
Total volume of fluid drained
Total output from intraoperatively placed drain plus any additional drainage performed percutaneously
Duration of drain placement
Duration of drain placement
Secondary outcomes
Haematoma
Haematoma
Number of percutaneous aspirations required
Number of percutaneous aspirations required
Duration of inpatient stay
Duration of inpatient stay
Number of patients with neck dissection complications relevant to drains management
Complications affecting drain management - chyle leak, pharyngocutaenous fistula, anastomotic leak
Locations
Sponsors and contacts
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St. James's Hospital, Ireland
Lead sponsor
Royal College of Surgeons, Ireland
Collaborator
This trial is not recruiting at the moment. You can still explore other options: