NCT03744273

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: —
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: Female
• Age: 20 Years – 70 Years
• Healthy volunteers: —

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.

Conditions

• Breast Neoplasms
• Mammaplasty
• Acellular Dermis

Interventions

Type	Name	Description
PROCEDURE	breast capsule biopsy

Timeline

• Start date: 2013-11-03
• Primary completion: 2015-05-26
• Completion: 2015-05-26
• First posted: 2018-11-16
• Last updated: 2018-11-19

Locations

1 site across 1 country: South Korea