Regenerative Tissue Matrix for Breast Reconstruction

This study has been completed.
Sponsor:
Information provided by:
Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT01027637
First received: December 7, 2009
Last updated: September 5, 2013
Last verified: December 2009
  Purpose

The purpose of this study is to evaluate the role of Alloderm tissue regenerative matrix used in many breast reconstruction operations. When this material is used in the abdomen it often stretches and sometimes needs to be replaced. Although we see good clinical results when used for breast reconstruction, there is no research regarding if or how the material changes in this location. The Alloderm is placed in the breast at the time the expander is placed, post-mastectomy. The expansion is started at the time of surgery and completed during a series of office visit. This process stretches the skin, underlying muscle and presumably the Alloderm. The goal of this study is to better understand the natural history of this material when used for breast reconstruction.

Our objective is to measure changes in the dimension of the tissue matrix material after it has been placed in the breast. These objective findings will be supplemented with a patient questionnaire specifically designed for breast surgery patients.

All patients will receive the standard preoperative work up, intraoperative procedures, and postoperative care indicated for patients undergoing implant breast reconstruction after mastectomy. Some of these patients will require use of the Alloderm to reconstruct the lower half of the breast pocket. This is already being done by plastic surgeons here at Henry Ford Hospital. The difference will be that the Alloderm tissue matrix used to reconstruct the lower part of the breast pocket for the study patients will have 4 millimeter metallic clips placed in it. Postoperatively these clips will be tracked by ultrasound done in the clinic. As the breast implant is normally expanded by adding saline, we believe the Alloderm matrix will stretch. The movement of these imperceptible clips will be tracked and measured to map the expansion of the matrix in response to the underlying implant stretching the overlying breast pocket and the skin envelope. The pattern of expansion will allow us to develop a mathematical model to describe the stretch pattern of Alloderm matrix used in breast reconstruction. This information will be supplemented with a validated questionnaire specifically designed by breast surgery patients. This will give us both an objective dimensional change in the breast reconstruction as well as a patient-centered evaluation of the reconstruction process.


Condition Intervention
Breast Cancer
Other: 5 mm vessel clips

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: In Situ Elasticity of Alloderm® in Breast Reconstruction

Resource links provided by NLM:


Further study details as provided by Henry Ford Health System:

Primary Outcome Measures:
  • Develop a mathematical model of the in situ stretch parameters of Alloderm® tissue matrix when used in breast reconstruction. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Define patient outcome and expectations with respect to prosthetic breast reconstruction with the use of Alloderm® tissue matrix. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: January 2010
Study Completion Date: June 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alloderm reconstruction
All patients recieving the intervention Alloderm for breast reconstruction
Other: 5 mm vessel clips
evenly placed vessel clips placed at surgery and tracked by ultrasound
Other Names:
  • Alloderm
  • acellular regenerative tissue matrix

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Inclusion of all females from ages 18 and older who undergoing prosthetic breast reconstruction and will require alloderm for lower pole reconstruction.-

Exclusion Criteria:

Exclusion criteria include perioperative radiation. History of allergic reaction to the allograft or its components or the metallic clips.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01027637

Locations
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Henry Ford Health System
Investigators
Principal Investigator: aamir siddiqui, md Henry Ford Health System
  More Information

No publications provided

Responsible Party: AamirSiddiqui, MD, Division of Plastic Surgery, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT01027637     History of Changes
Other Study ID Numbers: HFHS-PS1209, PS1209
Study First Received: December 7, 2009
Last Updated: September 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Henry Ford Health System:
breast reconstruction
tissue expander
Alloderm
tissue matrix

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 16, 2014