Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:25 PM
Ignite Modification Date:
2025-12-24 @ 2:25 PM
NCT ID:
NCT02891759
Brief 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.
Study:
NCT02891759
Study Brief:
Protocol Section:
NCT02891759