Single center, randomized, prospective, comparative study to evaluate the efficacy and safety according to type of acellular dermal matrix when being applied for reconstruction of defect areas after breast conserving surgery in breast cancer patients
- Conditions
- Neoplasms
- Registration Number
- KCT0008087
- Lead Sponsor
- Inje University Busan Paik Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 200
All subjects can participate in the clinical trial only when all of the following criteria are met.
? Those aged over 20 years old and up to 70 years old
? Patients with histopathologically confirmed breast cancer
? The patients planning to undergo breast conserving surgery with MegaDerm(diced type or sheet type) where being applied for reconstruction of defect areas
If any of the following items apply, the subject is excluded from the clinical trial.
? In case of mastectomy additionally because of local recurrent after breast conserving surgery
? Who underwent total mastectomy
? Uncontrolled severe infection
? Autoimmune disease
? Coagulation disorder (it is possible be enrolled, if the patients take the Aspirin or Plavix)
? Other patients who were judged to be difficult to participate in this study by the investigator
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method aesthetic outcome evaluation
- Secondary Outcome Measures
Name Time Method patients satisfaction evaluation;capsular contracture evaluation;complication evaluation