Tissue Expander/Implant Reconstruction: A Single-Blinded, Randomized, Controlled Trial
Public ClinicalTrials.gov record NCT00639106. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
The Use of Alloderm in Two-Stage, Tissue Expander/Implant Reconstruction: A Single-Blinded, Randomized, Controlled Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Following mastectomy (removal of your breast), reconstruction of your breast(s) can be performed using tissue expanders and implants. At the same operation as your mastectomy, a tissue expander is put under the skin and muscles of your chest. Following your surgery, the tissue expander is gradually filled with salt water over a period of months. Once the expander is filled to the size of your new breast, a second operation is performed. At this time, the tissue expander is removed and a permanent breast implant is placed. This is a standard procedure. We are interested in learning about the use of AlloDerm in breast reconstruction. AlloDerm can be used instead of some of your own chest muscles, in order to cover and protect a tissue expander. We want to know if the use of AlloDerm can decrease your pain or discomfort after surgery and after the filling of your tissue expander. AlloDerm is made from human tissue. When AlloDerm is made all the cells that could cause your body to reject it are removed. When it is placed in your chest, your own cells will then grow into the AlloDerm, causing it to act like the muscle it is replacing. In this study, you will either have reconstruction with AlloDerm or without AlloDerm.
Study identification
- NCT ID
- NCT00639106
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 70 participants
Conditions and interventions
Conditions
Interventions
- Alloderm, Questionnaires Procedure
- Without ALLODERM, Questionnaires Procedure
Procedure
Eligibility (public fields only)
- Age range
- 21 Years to 75 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 29, 2008
- Primary completion
- Sep 30, 2018
- Completion
- Sep 30, 2018
- Last update posted
- Oct 2, 2018
2008 – 2018
United States locations
- U.S. sites
- 3
- U.S. states
- 3
- U.S. cities
- 3
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| University of North Carolina School of Medicine | Chapel Hill | North Carolina | 27514 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00639106, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 2, 2018 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00639106 live on ClinicalTrials.gov.