Prospective, randomized, subject single-blind, double-arm study to evaluate the outcome of ADM without basement membrane in prosthetic breast reconstructio
- Conditions
- Symptoms, signs and abnormal clinical and laboratory findings, NEC
- Registration Number
- KCT0005852
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 60
Breast cancer patients aged 20 years or older and under 80 years of age who undergo breast reconstruction immediately after total mastectomy
1) Those who have previously had mastectomy, breast augmentation, or breast reconstruction
2) When both breasts are performed at the same time or when the opposite side is performed
3) When inserting an expander
4) Patients who have undergone organ transplant and are taking immunosuppressants
5) Those whose mental state may affect the progress of clinical trials due to alcohol and drug abuse
6) Those who are unable to conduct the survey conducted in this clinical trial
7) Those who participated in other clinical trials within 120 days before screening
8) When other investigators determine that it is inappropriate for this clinical trial
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Postoperative chemotherapy and radiation therapy
- Secondary Outcome Measures
Name Time Method Vital sign (Blood pressure, pulse, body temperature);Adverse effect(Previous abdominal resection, augmentation, reconstruction, dilator insertion, organ transplantation, taking immunosuppressants, alcohol and drug abuse, etc.);Breast reconstruction surgery;Evaluate the progress of surgery and the presence of complications