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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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KCT |
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Last refreshed on:
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16 December 2019 |
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Main ID: |
KCT0003886 |
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Date of registration:
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2019-05-03 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Volume replacement with diced acellular dermal matrix in oncoplastic breast conserving surgery
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Scientific title:
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Clinical efficacy of Megaderm for breast cancer patients receiving conservation |
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Date of first enrolment:
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2017-12-15 |
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Target sample size:
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120 |
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Recruitment status: |
Completed |
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URL:
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http://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=15435 |
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Study type:
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Observational Study |
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Study design:
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Observational Study Model : Case-only, Time Perspective : Prospective, Enrollment : 120, Biospecimen Retention : Not collect nor Archive
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Phase:
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NA
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Hongki
Gwak |
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Address:
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St. Vincent’s Hospital, College of Medicine, The Catholic University of Korea, 93 Jungbu-daero, Paldal-gu, Suwon 16247, Korea.
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Telephone:
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+82-31-249-8986 |
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Email:
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ghosthki@naver.com |
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Affiliation:
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The Catholic University of Korea, St. Vincent's Hospital |
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Name:
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Young-Jin
Suh |
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Address:
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St. Vincent’s Hospital, College of Medicine, The Catholic University of Korea, 93 Jungbu-daero, Paldal-gu, Suwon 16247, Korea.
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Telephone:
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+82-31-249-8695 |
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Email:
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youngjin.suh@gmail.com |
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Affiliation:
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The Catholic University of Korea, St. Vincent's Hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria: Women under 20 years of age and under 80 years of age who were diagnosed with breast cancer and selected conservative surgery. Patients who are allowed to use the Megaderm and who can be followed up for more than 2 months after surgery.
Exclusion criteria: Patients with infectious diseases, autoimmune diseases, blood clotting disorders
Patients with adverse reactions to primary antibiotics
Patients with suspected inflammatory infections before the operation
pregnant woman
Patients who were judged by the clinical trial leader to be difficult to collect.
Age minimum:
20(Year)
Age maximum:
80(Year)
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Neoplasms
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Primary Outcome(s)
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cosmetic satisfaction
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Secondary Outcome(s)
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surgical complication
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Source(s) of Monetary Support
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The Catholic University of Korea, St. Vincent's Hospital
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Ethics review
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Status: Submitted approval
Approval date:
Contact:
Institutional Review Board of the Catholic University of Korea
+82-2-2258-8212
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Results
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Results available:
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Date Posted:
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03/05/2019 |
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Date Completed:
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URL:
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