Compare Outcomes Between Two Acellular Dermal Matrices
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 22 - 70 |
| Updated: | 9/5/2018 |
| Start Date: | January 31, 2017 |
| End Date: | April 30, 2020 |
| Contact: | Terence M Myckatyn, M.D. |
| Email: | myckatyn@wustl.edu |
| Phone: | 314-996-8800 |
A Single-Blinded Randomized Prospective Trial to Compare Outcomes Between Two Acellular Dermal Matrices Used for Immediate, Post-Mastectomy Breast Reconstruction
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.
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.
Inclusion Criteria:
- Sex: Females
- Age: 22 to 70 years old
- Preoperative surgical plan: Immediate placement subpectoral (subpectoral and
postpectoral are synonymous) tissue expander with ADM or Immediate placement
prepectoral tissue expander or implant with ADM
- Mastectomy type: Skin-sparing or nipple-sparing mastectomy with or without sentinel
lymph node biopsy; may be unilateral or bilateral mastectomy
- Able to understand and willing to sign IRB approved written informed consent document.
Exclusion Criteria:
-Pregnant and/or breastfeeding.
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Terence M Myckatyn, M.D.
Phone: 314-996-8800
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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