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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02967146
Other study ID # 2016-08-194-002
Secondary ID
Status Recruiting
Phase Phase 3
First received November 16, 2016
Last updated January 3, 2017
Start date November 2016

Study information

Verified date January 2017
Source Samsung Medical Center
Contact Seok won Kim, MD
Phone +82-2-3410-2375
Email seokwon1.kim@samsung.com
Is FDA regulated No
Health authority Korea: Ministry of Food and Drug Safety
Study type Interventional

Clinical Trial Summary

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


Description:

A Multicenter Double-blinded, Randomized Study


Recruitment information / eligibility

Status Recruiting
Enrollment 170
Est. completion date
Est. primary completion date November 2017
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility 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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention


Intervention

Device:
adhesive barrier
After having axillary dissection, investigator has to inject the mediclore on op site directly and suture the site.

Locations

Country Name City State
Korea, Republic of Samsung Medical Center Seoul City

Sponsors (1)

Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary sum of ROM(range of motion) 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 4weeks No
Secondary sum of ROM(range of motion) comparision of the differences of sum of ROM between two groups ROM: forward flexion and horizontal abduction 24weeks No
Secondary pain assessment (numeric pain rating scale) to compare the differences of the pain related with motions of upper limbs 4weeks, 24weeks Yes
Secondary Scoring DASH(Disablities of the arm, shoulder and hand) to compare the differences of the DASH score 4weeks, 24weeks No
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