At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Acellular Dermal Matrix in One-Stage Breast Reconstruction: A RCT
In Brief
A clinical study evaluating One-stage dermal matrix/implant procedure and Two-stage tissue expander/implant procedure for Breast Cancer. Completed, enrolled 198 participants across 4 sites.
Detailed Summary
Currently the two-stage tissue expander/implant (TE/I) technique is the standard breast reconstructive option for breast cancer patients selected for immediate, skin-sparing mastectomy. This procedure has been demonstrated to be oncologically safe in patients with specific criteria for early stage breast cancer. The primary drawback, however, is that it requires two separate procedures under general anesthesia and multiple office visits for expander inflation to create the breast mound. Acellular dermal matrix has gained widespread acceptance for use in breast reconstruction and other areas and has the potential to provide support to the breast implant without tissue expansion in a one-stage procedure. The purpose of the study is to test this new procedure and to evaluate the impact of one-stage breast reconstruction using acellular dermis compared to the standard two-stage expander/implant technique on measures of patient satisfaction and quality of life.
Study Details
Timeline
Interventions
One-stage breast reconstruction with dermal matrix and implant
Two-stage breast reconstruction with tissue expander and implant