Capsule Biopsy in Acellular Dermal Matrix-based Prosthetic Breast Reconstruction: a Prospective Pilot Study

Samsung Medical Center

Status: Completed

Conditions: Mammaplasty; Breast Neoplasms; Acellular Dermis

Treatments: Procedure: breast capsule biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT03744273

2012-03-028

Details and patient eligibility

About

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.

Sex: Female

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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