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

NCT03744273 | Completed

• 1 other identifier: 2012-03-028
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms; Mammaplasty; Acellular Dermis

Outcome Measures

Primary Outcomes (1)

• histology scoring

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

  immediate after biopsy

Interventions

breast capsule biopsy PROCEDURE

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jai-Kyong Pyon, MD,PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Principal Investigator

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: November 16, 2018
• Study Start: November 3, 2013
• Primary Completion: May 26, 2015
• Study Completion: May 26, 2015
• Last Updated: November 19, 2018

Record last verified: 2018-11

Locations

KR (1)