RADA16 for Reducing Drain Output Trajectory Following Neck Dissection

NCT06178237 | Not Yet Recruiting

• 1 other identifier: 000117
• Study Type: interventional
• Target: 208
• Locations: 0 countries
• Sites: N/A

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 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

Head and Neck Cancer

Keywords

seroma

Outcome Measures

Primary Outcomes (2)

• Total volume of fluid drained

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

  3 months

• Duration of drain placement

  Duration of drain placement

  Until drain removal, usually within 2 weeks

Secondary Outcomes (4)

• Haematoma

  Usually within 1 week

• Number of percutaneous aspirations required

  3 months

• Duration of inpatient stay

  3 months

• Number of patients with neck dissection complications relevant to drains management

  3 months

Study Arms (2)

Standard of care

NO INTERVENTION

Standard of care post-neck dissection

Standard of care plus Purabond

EXPERIMENTAL

Standard of care post-neck dissection plus Purabond

Device: Purabond

Interventions

Purabond DEVICE

Application of Purabond to surgical field

Also known as: RADA16

Standard of care plus Purabond

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• St. James's Hospital, Ireland: lead
• Royal College of Surgeons, Ireland: collaborator

MeSH Terms

Conditions

Head and Neck Neoplasms; Seroma

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Gerard Sexton

CONTACT

014103000; gerardsexton@rcsi.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Registrar in Otolaryngology

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: December 20, 2023
• Study Start: March 1, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 20, 2023

Record last verified: 2023-12