A Retrospective Assessment of OviTex PRS (OviTex)

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Retrospective Assessment of OviTex PRS (OviTex) Permanent and Resorbable Devices in Subjects Who Have Previously Undergone a Breast Reconstruction

Conditions
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Reconstructive Surgical Procedures

Intervention / Treatment
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* Device: OviTex® PRS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient was between 18 years and 70 years of age (inclusive) at the time of surgery. 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. Patient is 6-months or more post initial surgical procedure. Exclusion Criteria: Patient received a textured expander or implant. Patient was a nicotine user (including smokeless, vaporized, etc.) within 4-weeks preceeding their index procedure. Patient was marijuana user (including smokeless, vaporized, etc.) within 4-weeks preceding their index procedure. 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 exclusion criteria (if applicable): 1. Patient has a history of a psychological condision, drug or alcohol abuse which may interfere with their ability to adhere to the follow-up requirements.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: OviTex® 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence of relevant (S)AEs within 24 months of OviTex® PRS implantation. | Retrospective - Prospective assessment | 24 months | 
| Narcotic usage | Retrospective - Prospective assessment | 24 months | 
| Hospitalization length of stay | Retrospective - Prospective assessment | At procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Expander/Implant Exchange | Retrospective - Prospective assessment | 24-months | 
| Intraoperative Fill Volume / Number and Volume of Fill Visits | Retrospective - Prospective assessment | 24 months | 
| Independent aesthetic assessment of each treated breast as measured by Telemark Breast Score | Image aesthetic assessment | 24 months | 
| Independent assessment of breast ptosis as measured by the Rainbow Scale | Retrospective - Prospective assessment | 24-months |