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NCT01561287 · ClinicalTrials.gov registry record · Phase 4
A Comparison of Dermal Autograft to AlloDerm in Breast Reconstruction
A Phase 4 study of Breast Cancer and Breast Reconstruction, sponsored by University of Kentucky.
- Completed
- Registry status
- Phase 4
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT01561287: Completed Phase 4 study of Breast Cancer and Breast Reconstruction, sponsored by University of Kentucky.
NCT01561287 is a Phase 4 study of Breast Cancer and Breast Reconstruction that has completed, run by University of Kentucky. The registered enrollment target is 48 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01561287, a Phase 4 study of Breast Cancer and Breast Reconstruction, has completed, sponsored by University of Kentucky.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
To accurately measure the neovascularization of the implants, the number of blood vessels per 40x high-power field (hpf) will be counted on the slides stained with Factor VIII. Any brown-staining endothelial cell or endothelial-cell cluster, clearly separate from adjacent microvessel and other connective-tissue elements, will be considered a single, countable microvessel. Vessel lumens, although usually present, will not be necessary for a structure to be defined as a microvessel, and red cells
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 |
What the finished NCT01561287 record still lists
NCT01561287 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower).
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.
NCT01561287 reports a single indexed study location in Kentucky.
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.
What interventions are being tested in trial NCT01561287?
The interventions under investigation include: Dermal Autograft (PROCEDURE), AlloDerm (PROCEDURE).
Who is sponsoring clinical trial NCT01561287?
This trial is sponsored by University of Kentucky, which has 54 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01561287's enrollment target sits among peer trials
48 821st of 1224 higher than 394 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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