Prevention of post-operative seroma by collagen-based sealant patch following super-selective neck dissection in thyroid surgery

Phase 4

• Conditions: ymphatic leakage and seroma after thyroidectomy with super-selective neck dissection; T81.8; Other complications of procedures, not elsewhere classified

• Registration Number: DRKS00013064
• Lead Sponsor: Medizinische Hochschule Hannover

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-08
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Indication of super-selective neck dissection during thyroidectomy

Exclusion Criteria

Coagulation disorders, radical modified neck dissection, <18 years of age, advanced thyroid carcinoma with infiltration of surrounding tissue, primary or secondary hyperparathyreoidism, previous neck surgery, pregnancy, lactation, intolerance for Hemopatch or its ingredients

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post-operative hospital discharge 24h after operation<br>

Secondary Outcome Measures

Name	Time	Method
Wound collection requiring intervention, post-operative pain (pain score on day 1 after surgery measured on a visual analogue scale (VAS) from 0 (no pain) to 10 (worst pain imaginable)) daily during hospitalisation, reoperation, wound infection, transient voice change, persistent recurrent laryngeal nerve palsy, volume of postoperative seroma