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Regenerative Tissue Matrix for Breast Reconstruction

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ClinicalTrials.gov Identifier: NCT01027637
Recruitment Status : Completed
First Posted : December 8, 2009
Last Update Posted : September 6, 2013
Information provided by:
Henry Ford Health System

Brief Summary:

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 or disease Intervention/treatment
Breast Cancer Other: 5 mm vessel clips

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: In Situ Elasticity of Alloderm® in Breast Reconstruction
Study Start Date : January 2010
Primary Completion Date : February 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Develop a mathematical model of the in situ stretch parameters of Alloderm® tissue matrix when used in breast reconstruction. [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Define patient outcome and expectations with respect to prosthetic breast reconstruction with the use of Alloderm® tissue matrix. [ Time Frame: 18 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01027637

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

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 ( Other Grant/Funding Number: Lifecell )
First Posted: December 8, 2009    Key Record Dates
Last Update Posted: September 6, 2013
Last Verified: December 2009

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

Additional relevant MeSH terms:
Glucuronyl glucosamine glycan sulfate
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Hypoglycemic Agents
Physiological Effects of Drugs