Back to resultsAnti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®) After Axillary Dissection for Breast Cancer
Primary Purpose
Breastcancer, Surgery: Axillary Dissection
Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
adhesive barrier
Sponsored by
About this trial
This is an interventional prevention trial for Breastcancer
Eligibility Criteria
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)
Sites / Locations
- Samsung Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Mediclore
Not done
Arm Description
Standard treatment for surgery
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
sum of ROM(range of motion)
comparision of the differences of sum of ROM between two groups ROM: forward flexion and horizontal abduction
pain assessment (numeric pain rating scale)
to compare the differences of the pain related with motions of upper limbs
Scoring DASH(Disablities of the arm, shoulder and hand)
to compare the differences of the DASH score
Full Information
NCT ID
NCT02967146
First Posted
November 16, 2016
Last Updated
January 3, 2017
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02967146
Brief Title
Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®) After Axillary Dissection for Breast Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breastcancer, Surgery: Axillary Dissection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
170 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mediclore
Arm Type
Experimental
Arm Title
Not done
Arm Type
No Intervention
Arm Description
Standard treatment for surgery
Intervention Type
Device
Intervention Name(s)
adhesive barrier
Intervention Description
After having axillary dissection, investigator has to inject the mediclore on op site directly and suture the site.
Primary Outcome Measure Information:
Title
sum of ROM(range of motion)
Description
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
Time Frame
4weeks
Secondary Outcome Measure Information:
Title
sum of ROM(range of motion)
Description
comparision of the differences of sum of ROM between two groups ROM: forward flexion and horizontal abduction
Time Frame
24weeks
Title
pain assessment (numeric pain rating scale)
Description
to compare the differences of the pain related with motions of upper limbs
Time Frame
4weeks, 24weeks
Title
Scoring DASH(Disablities of the arm, shoulder and hand)
Description
to compare the differences of the DASH score
Time Frame
4weeks, 24weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seok won Kim, MD
Phone
+82-2-3410-2375
Email
seokwon1.kim@samsung.com
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul City
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sung Min Park, MD
Phone
+82-2-3410-3660
Email
gs_sm.park@samsung.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
34352935
Citation
Choi HJ, Ryu JM, Chae BJ, Kim EK, Min JW, Shin HJ, Nam SJ, Yu J, Lee JE, Lee SK, Kim SW. Effect of Poloxamer-Based Thermo-Sensitive Sol-Gel Agent on Upper Limb Dysfunction after Axillary Lymph Node Dissection: A Double-Blind Randomized Clinical Trial. J Breast Cancer. 2021 Aug;24(4):367-376. doi: 10.4048/jbc.2021.24.e30. Epub 2021 Jun 17.
Results Reference
derived
Learn more about this trial
Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®) After Axillary Dissection for Breast Cancer
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