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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mediclore | Experimental |
| |
| Not done | No Intervention | Standard treatment for surgery |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adhesive barrier | Device | After having axillary dissection, investigator has to inject the mediclore on op site directly and suture the site. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| sum of ROM(range of motion) | comparision of the differences of sum of ROM between two groups ROM: forward flexion and horizontal abduction | 24weeks |
| pain assessment (numeric pain rating scale) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seok won Kim, MD | Contact | +82-2-3410-2375 | seokwon1.kim@samsung.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Recruiting | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34352935 | Derived | 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. |
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to compare the differences of the pain related with motions of upper limbs
| 4weeks, 24weeks |
| Scoring DASH(Disablities of the arm, shoulder and hand) | to compare the differences of the DASH score | 4weeks, 24weeks |