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

Phase 3

• Conditions: Surgery: Axillary Dissection; Breastcancer
• Interventions: Device: adhesive barrier

• Registration Number: NCT02967146
• Lead Sponsor: Samsung Medical Center

Brief Summary

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

Detailed Description

A Multicenter Double-blinded, Randomized Study

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-16
• Study First Submitted QC: 2016-11-16
• Study First Posted: 2016-11-18
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-03
• Last Update Posted: 2017-01-05
• Primary Completion: 2017-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 170

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mediclore	adhesive barrier	-

Primary Outcome Measures

Name	Time	Method
sum of ROM(range of motion)	4weeks	to compare the differences of sum of ROM between two groups comparision of the differences of sum of ROM between two groups ROM: forward flexion and horizontal abduction

Secondary Outcome Measures

Name	Time	Method
pain assessment (numeric pain rating scale)	4weeks, 24weeks	to compare the differences of the pain related with motions of upper limbs
sum of ROM(range of motion)	24weeks	comparision of the differences of sum of ROM between two groups ROM: forward flexion and horizontal abduction
Scoring DASH(Disablities of the arm, shoulder and hand)	4weeks, 24weeks	to compare the differences of the DASH score

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul City, Korea, Republic of