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

NCT04904653 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2024-03-06

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Hemopatch

HEMOPATCH Sealing Hemostat ("HEMOPATCH") consists of a soft, thin, pliable, flexible pad of collagen derived from bovine dermis, coated with NHS-PEG (pentaerythritol polyethylene glycol ether tetra-succinimidyl glutarate). Due to its flexible structure, the application of HEMOPATCH to the site where hemostasis / sealing is desired is easily controlled. For differentiation, the non-coated side is marked with blue squares using a biocompatible colorant. HEMOPATCH is supplied in the following 3 sizes: * HEMOPATCH 27 x 27 mm * HEMOPATCH 45 x 45 mm * HEMOPATCH 45 x 90 mm

OTHER

Control group

No sealant (liquid, gel or patch) + suction drain

Sponsors & Collaborators

  • Asociación De Cirujanos De Mama De Toledo

    collaborator OTHER

  • Instituto de Investigación Hospital Universitario La Paz

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-08
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04904653 on ClinicalTrials.gov