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
About this trial
This is an interventional trial for Breast Neoplasms
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
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
NCT ID
NCT03744273
First Posted
November 14, 2018
Last Updated
November 15, 2018
Sponsor
Samsung Medical Center
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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