Reconstructive Surgical Procedures
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEOviTex® PRS
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.
Sponsors
Tela Bio Inc
MCRA
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Inclusion criteria
1. Patient was between 18 years and 75 years of age (inclusive) at the time of surgery. 2. At the time of surgery, the patient received an OviTex PRS Permanent (R20143 or R20243) or Resorbable (R20152 or R20252) implant in conjunction with an implant-based breast reconstruction. 3. Patient has undergone their initial surgical procedure and exchange surgery (if applicable).
Exclusion criteria
1. Patient received a textured permanent breast implant. 2. Patient was a nicotine user (including smokeless, vaporized, etc.) within 4-weeks preceeding their index procedure. 3. Patient had previously undergone radiation therapy to the chest wall prior to index surgery. Additional prospective inclusion criteria (if applicable): 1\. Patient agrees to return in-person for prospective portion including the completion of photographs. Additional prospective
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The occurrence of relevant (S)AEs within 24 months of OviTex® PRS implantation. | 24 months | Retrospective - Prospective assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Expander/Implant Exchange | 24-months | Retrospective - Prospective assessment |
| Intraoperative Fill Volume / Number and Volume of Fill Visits | 24 months | Retrospective - Prospective assessment |
| Independent aesthetic assessment of each treated breast as measured by Telemark Breast Score | 24 months | Image aesthetic assessment |
| Independent assessment of breast ptosis as measured by the Rainbow Scale | 24-months | Retrospective - Prospective assessment |
| Hospitalization length of stay | At procedure | Retrospective - Prospective assessment |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAsaf Yalif, MD
Y Plastic Surgery
Outcome results
None listed