Regenerative Tissue Matrix for Breast Reconstruction
Recruitment status was Not yet recruiting
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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 Reconstruction |
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 |
- 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 ]
- 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 ]
| Estimated Enrollment: | 30 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | August 2010 (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:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders 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.
Contacts and Locations| Contact: aamir siddiqui, md | 313-916-2683 | asiddiq1@hfhs.org |
| United States, Michigan | |
| Henry Ford Hospital | Not yet recruiting |
| Detroit, Michigan, United States, 48202 | |
| Contact: aamir siddiqui, md 313-916-2683 asiddiq1@hfhs.org | |
| 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: | January 29, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Henry Ford Health System:
|
breast reconstruction tissue expander Alloderm tissue matrix |
ClinicalTrials.gov processed this record on May 16, 2013