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

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.

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Key information

Conditions

Breast Neoplasms Acellular Dermis Breast Diseases Mammaplasty Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, 06351, South Korea

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

breast capsule biopsy

Procedure

Primary outcomes

histology scoring

Time frame: immediate after biopsy

semiquantitative histopathologic score system of biopsy specimens (reference: Basu et al., Plastic and Reconstructive Surgery, 126: 1842, 2010)

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Nov 16, 2018
Registry last updated: Nov 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed