Comparison of Efficacy of Reconstructive Surgery Methods using a Acellular Dermal Matrix(ADM) after Mastectomy in Breast Cancer Patients

Not Applicable

Recruiting

• Conditions: Neoplasms

• Registration Number: KCT0004798
• Lead Sponsor: Gachon University, Donginchoen Gil Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 September 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

1) Patients aged =19 years
2) Breast cancer patients who needed mastectomy
3) Patients who will be treated breast reconstruction after mastectomy
4) Patients who will use ADM for breast reconstruction
5) Patients who agree to a clinical trial and can be monitored within the trial period

Exclusion Criteria

1) Patients treated chemotherapy for cancer other than breast cancer
2) Patients with local recurrence or systemic transfer of breast cancer
3) Patients with infectious diseases, autoimmune diseases (especially rheumatoid diseases), and underlying diseases such as hemostatic disorder
4) Patients with systemic diseases other than breast cancer (especially diabetes, etc.)
5) Pregnant or lactating women
6) Patients with a history of radiation therapy
7) Patients judged by investigator that it is difficult to participate in the research (smokers, obesity, etc.)

Study & Design

• Study Type: Observational Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient's satisfaction score(BREAST-Q test)

Secondary Outcome Measures

Name	Time	Method
Patient's satisfaction score(BREAST-Q test);Visual analogue scale;Capsular Contracture and clinical efficacy / safety evaluation