Evaluation of a Human Acellular Dermal Matrix in Post Mastectomy Reconstruction

September 18, 2018 updated by: Musculoskeletal Transplant Foundation

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Mountain View, California, United States, 94040
        • Liu Plastic Surgery
      • San Jose, California, United States, 95124
        • Liu Plastic Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Flex HD Pliable Perforated HADM
Single Arm
Other: Flex HD Pliable Perforated HADM
Human Acellular Dermal Matrix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Types and incidence of complications
Time Frame: 6 months post reconstruction
Documentaiton of any medical and/or surgical problem requiring treatment that arises as a result of the reconstruction procedure
6 months post reconstruction

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aesthetic Outcomes
Time Frame: 6 months post reconstruction
Aesthetic outcomes evaluated by the operating surgeon and two independent board certified plastic surgeons with breast reconstruction expertise
6 months post reconstruction
Patient-Reported Outcomes
Time Frame: 6 months post reconstruction
Use of the Breast Q survey instrument
6 months post reconstruction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Musculoskeletal Transplant Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

October 6, 2014

First Submitted That Met QC Criteria

October 10, 2014

First Posted (Estimate)

October 13, 2014

Study Record Updates

Last Update Posted (Actual)

September 20, 2018

Last Update Submitted That Met QC Criteria

September 18, 2018

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MTF 13-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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