Acellular Dermis, Breast Neoplasms, Mammaplasty
Conditions
Brief summary
In this prospective study, breast capsule biopsy was performed in patients undergoing 2-stage expander-implant breast reconstruction to determine its use. Prospective clinical trial was designed for 10 consecutive patients as a pilot study and approved by IRB of Samsung Medical Center. From November 2013 to May 2015, full-thickness capsule biopsy specimen was obtained from acellular dermal matrix (ADM) capsule and from native subpectoral capsule (internal control) during expander-implant exchange. Biopsy specimens were scored for fibrosis and inflammatory reactions. This is completed study and its specific title, study objective, method, and results will be available online after scientific journal submission.
Interventions
PROCEDUREbreast capsule biopsy
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 70 Years
Inclusion criteria
* age between 20 and 70 * planning 2-stage expander-implant breast reconstruction using acellular dermal matrix * with no medical history such as diabetes, hypertension, or smoking * no surgical history
Exclusion criteria
* pregnant * newly detected medical or surgical condition * acellular dermal matrix loss due to allergic reaction or prosthetic infection * breast cancer recurrence * transfer to other institution * reconstruction give-up due to patient's wish * no biopsy score
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| histology scoring | immediate after biopsy | semiquantitative histopathologic score system of biopsy specimens (reference: Basu et al., Plastic and Reconstructive Surgery, 126: 1842, 2010) |
Countries
South Korea
Outcome results
None listed