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

Breastcancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02967146
• Other study ID #: 2016-08-194-002
• 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. 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

Related Conditions & MeSH terms

• Breast Neoplasms
• Breastcancer
• Surgery: Axillary Dissection

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