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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

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ClinicalTrials.gov Identifier: NCT02967146
Recruitment Status : Unknown
Verified January 2017 by Seok Won Kim, Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : November 18, 2016
Last Update Posted : January 5, 2017
Sponsor:
Information provided by (Responsible Party):
Seok Won Kim, Samsung Medical Center

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

Condition or disease Intervention/treatment Phase
Breastcancer Surgery: Axillary Dissection Device: adhesive barrier Phase 3

Detailed Description:
A Multicenter Double-blinded, Randomized Study

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : November 2016
Estimated Primary Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Poloxamer

Arm Intervention/treatment
Experimental: Mediclore Device: adhesive barrier
After having axillary dissection, investigator has to inject the mediclore on op site directly and suture the site.

No Intervention: Not done
Standard treatment for surgery



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. sum of ROM(range of motion) [ Time Frame: 24weeks ]
    comparision of the differences of sum of ROM between two groups ROM: forward flexion and horizontal abduction

  2. pain assessment (numeric pain rating scale) [ Time Frame: 4weeks, 24weeks ]
    to compare the differences of the pain related with motions of upper limbs

  3. Scoring DASH(Disablities of the arm, shoulder and hand) [ Time Frame: 4weeks, 24weeks ]
    to compare the differences of the DASH score



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02967146


Contacts
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Contact: Seok won Kim, MD +82-2-3410-2375 seokwon1.kim@samsung.com

Locations
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Korea, Republic of
Samsung Medical Center Recruiting
Seoul City, Korea, Republic of
Contact: Sung Min Park, MD    +82-2-3410-3660    gs_sm.park@samsung.com   
Sponsors and Collaborators
Samsung Medical Center

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Responsible Party: Seok Won Kim, MD, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02967146     History of Changes
Other Study ID Numbers: 2016-08-194-002
First Posted: November 18, 2016    Key Record Dates
Last Update Posted: January 5, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Chitosan
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Chelating Agents
Sequestering Agents
Hemostatics
Coagulants