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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-03

Study Completion Date

2015-05-26

Brief Summary

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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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Detailed Description

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Conditions

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Breast Neoplasms Mammaplasty Acellular Dermis

Interventions

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breast capsule biopsy

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No