The Effectiveness of Hemopatch® in the Reduction of Post-surgical Serous Drainage

Phase 4

Recruiting

• Conditions: Hemopatch; Breast Cancer; Axillary Lymphadenectomy
• Interventions: Other: Control group; Device: Hemopatch

• Registration Number: NCT04904653
• Lead Sponsor: Instituto de Investigación Hospital Universitario La Paz

Brief Summary

Hemopatch is an alternative to reduce morbidity associated with axillary lymphadenectomy surgery, possibly contributing to improved patient management, clinical outcomes, and hospital costs. We propose a multicenter, controlled, and randomized trial to study the efficacy of Hemopatch in reducing serous wound drainage.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-19
• Study First Submitted QC: 2021-05-24
• Study First Posted: 2021-05-27
• Study Start: 2021-11-08
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-06
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 118

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control group	No sealant (liquid, gel or patch) + suction drain
Hemopatch Group:	Hemopatch	Hemopatch + suction drainage

Primary Outcome Measures

Name	Time	Method
Total volume in milliliters (ml) of drainage	In the last 24 hours	Total volume in milliliters (ml) of drainage: To be measured in the hospital every day before discharge, and collected daily after discharge with a follow-up of phone calls or patient diaries during hospital visits until extraction drain.

Trial Locations

Locations (1)

General Surgery and Digestive System Service; 🇪🇸 Toledo, Spain