The objective of this retrospective-prospective, observational study is to evaluate the safety profile overall and within two device types of OviTex PRS in previous pre-pectoral or sub-pectoral implant-based breast reconstructions.
This study is organized as a retrospective-prospective, observational, multi-center study. The treatment group involved in the study received OviTex PRS during implant-based breast reconstruction. The reconstruction procedure was an immediate or two-stage unilateral or bilateral implant in either the sub-pectoral or pre-pectoral position. Results from this study are aimed to demonstrate an acceptable safety profile and to inform the study design and effectiveness endpoints of a future prospective study.
Study Type
OBSERVATIONAL
Enrollment
200
OviTex® PRS is a reinforced tissue matrix intended to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery.
Aesthetic Surgery Center
Naples, Florida, United States
Castrellon Aesthetic Surgery
South Miami, Florida, United States
Y Plastic Surgery
Alpharetta, Georgia, United States
The occurrence of relevant (S)AEs within 24 months of OviTex® PRS implantation.
Retrospective - Prospective assessment
Time frame: 24 months
Time to Expander/Implant Exchange
Retrospective - Prospective assessment
Time frame: 24-months
Intraoperative Fill Volume / Number and Volume of Fill Visits
Retrospective - Prospective assessment
Time frame: 24 months
Independent aesthetic assessment of each treated breast as measured by Telemark Breast Score
Image aesthetic assessment
Time frame: 24 months
Independent assessment of breast ptosis as measured by the Rainbow Scale
Retrospective - Prospective assessment
Time frame: 24-months
Hospitalization length of stay
Retrospective - Prospective assessment
Time frame: At procedure
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Massachusetts General Hospital
Boston, Massachusetts, United States
Janineh Plastic Surgery
Rochester Hills, Michigan, United States
David L. Abramson, MD
Englewood, New Jersey, United States
Capital Health
Pennington, New Jersey, United States
Strong Memorial Hospital
Rochester, New York, United States
Plastic Surgery Consultants
Columbia, South Carolina, United States
Dermatology Associates of San Antonio/Baptist Medical Center
San Antonio, Texas, United States
...and 1 more locations