Clinical trial · Interventional
RADA16 for Reducing Drain Output Trajectory Following Neck Dissection
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Purabond | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Standard of care
- description
- Standard of care post-neck dissection
- type
- EXPERIMENTAL
- label
- Standard of care plus Purabond
- description
- Standard of care post-neck dissection plus Purabond
- interventionNames
- Device: Purabond
Primary outcomes (2)
- measure
- Total volume of fluid drained
- timeFrame
- 3 months
- description
- Total output from intraoperatively placed drain plus any additional drainage performed percutaneously
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * Patients unable to satisfy all the above listed inclusion criteria.
References
Publications (0)
Data not yet available