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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Purabond

    Device

    Application of Purabond to surgical field

Treatment groups

208 Participants
are divided into 2 treatment groups
Group A: Standard of careNo intervention 0 interventions
Group B: Standard of care plus PurabondExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Total volume of fluid drained

Total output from intraoperatively placed drain plus any additional drainage performed percutaneously

Time frame
3 months
2

Duration of drain placement

Duration of drain placement

Time frame
Until drain removal, usually within 2 weeks

Secondary outcomes

1

Haematoma

Haematoma

Time frame
Usually within 1 week
2

Number of percutaneous aspirations required

Number of percutaneous aspirations required

Time frame
3 months
3

Duration of inpatient stay

Duration of inpatient stay

Time frame
3 months
4

Number of patients with neck dissection complications relevant to drains management

Complications affecting drain management - chyle leak, pharyngocutaenous fistula, anastomotic leak

Time frame
3 months

Other outcomes

Locations

This trial has no 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: