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Clinical Trials/NCT02967146
NCT02967146UnknownPhase 3

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

Samsung Medical Center2 sites in 2 countries170 target enrollmentStarted: November 2016Last updated:
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Conditions

Trial Snapshot

Phase
Phase 3
Enrollment
170
Locations
2
Primary Endpoint
sum of ROM(range of motion)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Outcomes

Primary Outcomes

sum of ROM(range of motion)

Time Frame: 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 Outcomes

  • pain assessment (numeric pain rating scale)(4weeks, 24weeks)
  • sum of ROM(range of motion)(24weeks)
  • Scoring DASH(Disablities of the arm, shoulder and hand)(4weeks, 24weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Seok Won Kim

MD

Samsung Medical Center

Study Sites (2)

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