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

Breast Neoplasms Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03744273
• Other study ID #: 2012-03-028
• Status: Completed
• Phase: N/A
• Start date: November 3, 2013
• Est. completion date: May 26, 2015

Study information

• Verified date: November 2018
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: May 26, 2015
• Est. primary completion date: May 26, 2015
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Acellular Dermis
• Breast Neoplasms
• Mammaplasty

Intervention

Procedure:
• breast capsule biopsy

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	histology scoring	semiquantitative histopathologic score system of biopsy specimens (reference: Basu et al., Plastic and Reconstructive Surgery, 126: 1842, 2010)	immediate after biopsy