A trial evaluating outcomes of immediate implant-based breast reconstruction using an acellular dermal matrix (ADM) (POBRAD trial)
Not Applicable
Completed
- Conditions
- Breast CancerCancerMalignant neoplasm of breast
- Registration Number
- ISRCTN67956295
- Lead Sponsor
- King's College of London (UK)
- Brief Summary
2013 results in https://doi.org/10.1016/j.ejso.2013.07.125 (added 30/01/2020)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 40
Inclusion Criteria
1. Any person older than 18 years of age meeting the inclusion criteria are eligible to the study
2. All post-mastectomy patients undergoing immediate implant-based, breast reconstruction requiring lower pole cover
Exclusion Criteria
1. Significant co-morbidities
2. Body mass index (BMI) >40
3. Locally advanced and/ or inflammatory breast cancer
4. Patients unable to provide informed consent to participate in trial
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Mastectomy-site complication rate<br> 2. Implant-related complication rate<br> 3. Return to theatre rate<br><br> Measured 1, 3 and 12 months post surgery<br>
- Secondary Outcome Measures
Name Time Method <br> 1. Cosmetic outcome<br> 2. Patient reported outcome<br> 3. Cost-benefit analysis<br>