Evaluation of a Human Acellular Dermal Matrix in Post Mastectomy Reconstruction

Breast Reconstruction Clinical Trial

Official title:

Reconstructive, Aesthetic and Patient Reported Outcomes Associated With the Use of Flex HD Pliable, Perforated Human Acellular Dermal Matrix in Implant-Based Breast Reconstruction: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02263261
• Other study ID #: MTF 13-03
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: November 2016

Study information

• Verified date: March 2015
• Source: Musculoskeletal Transplant Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Use of a HADM and implant in post-mastectomy breast reconstruction.

Description:

This is a prospective, single-site pilot study in which outcomes associated with the use of Flex HD® Pliable™ Perforated, Human Acellular Dermal Matrix and an implant which are used in post-mastectomy breast reconstruction will be obtained. The data collected will include reconstructive outcomes, aesthetic outcomes and patient-reported outcomes in order to ascertain advantages and disadvantages of using this particular HADM in post-mastectomy breast reconstruction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Scheduled to undergo a single or two-stage, tissue-assisted, implant breast reconstruction

• Mastectomy may be unilateral or bilateral, prophylactic or therapeutic

• Skin incision may be skin sparing, or nipple-areolar sparing

• Have signed written, informed consent

• Be at least 18 years of age

Exclusion Criteria:

• Patients undergoing autologous breast reconstruction

• Patients undergoing breast reconstruction following complications of breast augmentation, mastopexy, breast reduction, or breast conservation surgery (lumpectomy)

• Patients undergoing reconstruction after previously failed attempts at reconstruction

• Patients undergoing autologous breast reconstruction in conjunction with a tissue expander (such as a latissimus dorsi flap, DIEP flap)

• There will be no exclusions based on race or ethnicity

• BMI > 40

• Previous Radiation Treatment. Note: Post-operative radiation treatment does not exclude subjects from study continuation once enrolled.

Related Conditions & MeSH terms

• Breast Reconstruction
• Mastectomy

Intervention

Other:
• Flex HD Pliable Perforated HADM
Human Acellular Dermal Matrix

Locations

Country	Name	City	State
United States	Liu Plastic surgery	Mountain View	California
United States	Liu Plastic Surgery	San Jose	California

Sponsors (1)

Lead Sponsor	Collaborator
Musculoskeletal Transplant Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Types and incidence of complications	Documentaiton of any medical and/or surgical problem requiring treatment that arises as a result of the reconstruction procedure	6 months post reconstruction
Secondary	Aesthetic Outcomes	Aesthetic outcomes evaluated by the operating surgeon and two independent board certified plastic surgeons with breast reconstruction expertise	6 months post reconstruction
Secondary	Patient-Reported Outcomes	Use of the Breast Q survey instrument	6 months post reconstruction