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

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03744273
• Collaborator: (none)
• Location: 1
• Actual Duration (Months): 18.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasms; Mammaplasty; Acellular Dermis	Procedure: breast capsule biopsy	N/A

Study Design

• Study Type: Interventional
• Actual Study Start Date: Nov 3, 2013
• Actual Primary Completion Date: May 26, 2015
• Actual Study Completion Date: May 26, 2015

Outcome Measures

Primary Outcome Measures

1. histology scoring [immediate after biopsy]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 70 Years
• Sexes Eligible for Study: Female

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of	06351

Sponsors and Collaborators

• Samsung Medical Center

Investigators

• Principal Investigator: Jai-Kyong Pyon, MD,PhD, Samsung Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jai-Kyong Pyon, Professor, Principal Investigator, Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT03744273
• Other Study ID Numbers: 2012-03-028
• First Posted: Nov 16, 2018
• Last Update Posted: Nov 19, 2018
• Last Verified: Nov 1, 2018

• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Nov 19, 2018