RecruitingPhase 4NCT04904653

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

Randomized Controlled and Single Blind Clinical Trial in Women With Breast Cancer and Axillary Lymphadenectomy, to Evaluate the Effectiveness of Hemopatch® in the Reduction of Post-surgical Serous Drainage

Sponsor

Instituto de Investigación Hospital Universitario La Paz

Enrollment

118 participants

Start Date

Nov 8, 2021

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Hemopatch Axillary Lymphadenectomy

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether using a special absorbable patch (Hemopatch) placed during surgery reduces post-surgical fluid drainage (seroma) in women undergoing breast-conserving surgery plus axillary lymph node removal for breast cancer. **You may be eligible if...** - You are a woman aged 18 or older - You have breast cancer with lymph node involvement (N+) - You are scheduled for a lumpectomy or quadrantectomy plus axillary lymph node removal - At least 10 axillary lymph nodes are removed during surgery **You may NOT be eligible if...** - You are having a mastectomy (full breast removal) - You have had prior radiation to the affected area or previous axillary surgery - You have significant liver disease or poorly controlled diabetes - You have a known allergy to bovine proteins or PEG (ingredients in Hemopatch) - You are pregnant or tested positive for COVID-19 Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEHemopatch

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

OTHERControl group

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

Locations(1)

General Surgery and Digestive System Service

Toledo, Spain

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NCT04904653

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