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NCT02891759 · ClinicalTrials.gov registry record · Phase 2
Compare Outcomes Between Two Acellular Dermal Matrices
A Phase 2 study of Breast Cancer, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 320
- Enrollment target
- 1
- Study location
NCT02891759 is a Phase 2 study of Breast Cancer that has completed, run by Washington University School of Medicine. The registered enrollment target is 320 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02891759, a Phase 2 study of Breast Cancer, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 320 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will evaluate the performance of Alloderm RTU medium (LifeCell) vs. Cortiva 1mm Allograft Dermis (RTI Surgical®, Inc.). These are the thinnest versions of acellular dermal matrices (ADM) offered by both vendors and can be used for post-mastectomy breast reconstruction. Alloderm RTU medium has a thickness of 1.6±0.4 mm, while Cortiva 1mm Allograft Dermis has a thickness of 1.0±0.2 mm. In the context of breast reconstruction, these ADMs are used in the same manner. They may be inserted with a tissue expander immediately after skin- or nipple-sparing mastectomy. The investigators will examine breast-reconstruction associated complication rates, pre- and post-operative patient reported outcomes using the Breast Q, and physician reimbursement as well as direct hospital costs. The endpoint will be either exchange of the tissue expander for a permanent breast implant or autologous flap, explantation due to patient preference, development of a complication, or less common reasons. The investigators propose that Cortiva 1mm Allograft Dermis and Alloderm RTU will have equivalent complication and patient reported outcome rates as well as physician reimbursement, but that direct hospital cost will be less with Cortiva 1mm Allograft Dermis.
Conditions Studied
Interventions
- PROCEDURE Surgery
- OTHER Alloderm RTU
- OTHER Cortiva 1mm Allograft Dermis
- PROCEDURE Skin or nipple-sparing mastectomy
- OTHER Breast Q
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 320 participants |
| Start Date | 2017-01-31 |
| Est. Completion | 2022-10-27 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02891759
The ClinicalTrials.gov registry entry for NCT02891759 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 320 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (89% lower). The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Surgery is the first listed.
NCT02891759 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.
Frequently Asked Questions
What is clinical trial NCT02891759 about?
NCT02891759 is a clinical study titled "Compare Outcomes Between Two Acellular Dermal Matrices". This study will evaluate the performance of Alloderm RTU medium (LifeCell) vs. Cortiva 1mm Allograft Dermis (RTI Surgical®, Inc.). These are the thinnest versions of acellular dermal matrices (ADM) offered by both vendors and can be used for post-mastectomy breast reconstruction. Alloderm RTU medium...
What is the current status of trial NCT02891759?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 320 participants. The study started on 2017-01-31. Estimated completion is 2022-10-27.
What conditions does trial NCT02891759 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT02891759?
The interventions under investigation include: Surgery (PROCEDURE), Alloderm RTU (OTHER), Cortiva 1mm Allograft Dermis (OTHER), Skin or nipple-sparing mastectomy (PROCEDURE), Breast Q (OTHER).
Who is sponsoring clinical trial NCT02891759?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02891759 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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