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

Primary Purpose

Breast Neoplasms, Mammaplasty, Acellular Dermis

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
breast capsule biopsy
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional trial for Breast Neoplasms

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)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

Sites / Locations

  • Samsung Medical Center

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 14, 2018
Last Updated
November 15, 2018
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03744273
Brief Title
Capsule Biopsy in Acellular Dermal Matrix-based Prosthetic Breast Reconstruction: a Prospective Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
November 3, 2013 (Actual)
Primary Completion Date
May 26, 2015 (Actual)
Study Completion Date
May 26, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, Mammaplasty, Acellular Dermis

7. Study Design

Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
breast capsule biopsy
Primary Outcome Measure Information:
Title
histology scoring
Description
semiquantitative histopathologic score system of biopsy specimens (reference: Basu et al., Plastic and Reconstructive Surgery, 126: 1842, 2010)
Time Frame
immediate after biopsy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jai-Kyong Pyon, MD,PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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