Regenerative Tissue Matrix for Breast Reconstruction

NCT01027637 | Completed DMC

• 2 other identifiers: HFHS-PS1209PS1209
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

breast reconstruction; tissue expander; Alloderm; tissue matrix

Outcome Measures

Primary Outcomes (1)

• Develop a mathematical model of the in situ stretch parameters of Alloderm® tissue matrix when used in breast reconstruction.

  18 months

Secondary Outcomes (1)

• Define patient outcome and expectations with respect to prosthetic breast reconstruction with the use of Alloderm® tissue matrix.

  18 months

Study Arms (1)

Alloderm reconstruction

EXPERIMENTAL

All patients recieving the intervention Alloderm for breast reconstruction

Other: 5 mm vessel clips

Interventions

5 mm vessel clips OTHER

evenly placed vessel clips placed at surgery and tracked by ultrasound

Also known as: Alloderm, acellular regenerative tissue matrix

Alloderm reconstruction

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Alloderm

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• aamir siddiqui, md

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 7, 2009
• First Posted: December 8, 2009
• Study Start: January 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: June 1, 2011
• Last Updated: September 6, 2013

Record last verified: 2009-12

Locations

US (1)