Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®) After Axillary Dissection for Breast Cancer

Samsung Medical Center

Status and phase: Unknown; Phase 3

Conditions: Surgery: Axillary Dissection; Breastcancer

Treatments: Device: adhesive barrier

Study type: Interventional

Funder types: Other

Identifiers

NCT02967146

2016-08-194-002

Details and patient eligibility

About

Anti-adhesive effect and Safety of a mixed solid of poloxamer, gelatin and chitosan(Mediclore®) after axillary dissection for breast cancer

Full description

A Multicenter Double-blinded, Randomized Study

Enrollment: 170 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• the patients needed axillary dissection in breast cancer
• Written informed consent
• Patients without clinically significant lab
• the patients who are diagnosed 'positive for metastasis' by sentinel lymph node biopsy

Exclusion criteria

• having enrolled another clinical trials within 1 month
• Immunosuppression or autoimmune disease
• Anticoagulant, general steroids within a week from surgery
• Incompatible medications
• Serious diseases (heart failure, renal failure, liver failure, uncontrolled hypertension, diabetes mellitus, coagulation deficiencies)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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170 participants in 2 patient groups

Mediclore

Experimental group

Treatment:

Device: adhesive barrier

Not done

No Intervention group

Description:

Standard treatment for surgery