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A Comparison of Dermal Autograft to AlloDerm in Breast Reconstruction
NCT01561287 · View on ClinicalTrials.gov ↗
Study Summary
Breast Cancer affects about 1 out of 8 American women. Twenty percent of breast cancer patients undergo some form of breast reconstruction. Several types of reconstructive procedures are available for appropriate patients. A reconstructive sequence consisting of a tissue expander followed by permanent implant placement is a popular choice for many women. In the past several years, acellular dermal matrices (allografts) have been used at the time of tissue expander placement to extend submuscular coverage. Reported benefits include the ability to initially fill the expander to a greater extent, improved control of the inframammary crease, and possible decrease in capsular contracture rate. Potential disadvantages of dermal allografts include foreign body reaction, incomplete tissue integration, or increased infection rates. The latter is especially worrisome, as infection in the setting of a tissue expander often necessitates the removal of the implant and interruption of the reconstructive sequence. There have been a few scattered reports of the use of dermal autografts in implant-based breast reconstruction, but they have not been widely used. Dermal autografts carry the potential benefit of improved tissue integration and lowered complication rates. However, to date there have been no studies which compare acellular dermal allograft matrices to dermal autograft for use in breast reconstruction. The objectives of this study are to compare dermal allograft to dermal autograft with respect to cost, tissue integration, patient satisfaction with scar, and complication profile in patients undergoing mastectomy followed by tissue expander/implant reconstruction.
Conditions Studied
Interventions
- PROCEDURE Dermal Autograft
- PROCEDURE AlloDerm
Study Locations (1)
Kentucky
- University of Kentucky Chandler Medical Center — Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2011-07 |
| Est. Completion | 2016-05 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01561287
The ClinicalTrials.gov registry entry for NCT01561287 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Kentucky, which has 47 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions — of which Dermal Autograft is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01561287 reports 1 study location spanning 1 distinct geographic area — top geographies include Kentucky. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01561287 about?
NCT01561287 is a clinical study titled "A Comparison of Dermal Autograft to AlloDerm in Breast Reconstruction". Breast Cancer affects about 1 out of 8 American women. Twenty percent of breast cancer patients undergo some form of breast reconstruction. Several types of reconstructive procedures are available for appropriate patients. A reconstructive sequence consisting of a tissue expander followed by permane...
What is the current status of trial NCT01561287?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 48 participants. The study started on 2011-07. Estimated completion is 2016-05.
What conditions does trial NCT01561287 study?
This clinical trial studies the following conditions: Breast Cancer, Breast Reconstruction, Mastectomy Related Lymphedema. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01561287?
The interventions under investigation include: Dermal Autograft (PROCEDURE), AlloDerm (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01561287?
This trial is sponsored by University of Kentucky, which has 47 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01561287 being conducted?
This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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