RecruitingNCT05736848

A Retrospective Assessment of OviTex PRS (OviTex)

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


Sponsor

Tela Bio Inc

Enrollment

200 participants

Start Date

Sep 27, 2022

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study retrospectively — and in some cases prospectively — evaluates the outcomes of breast reconstruction using the OviTex PRS mesh, a biological and synthetic composite material used to support breast tissue after mastectomy. When a patient has a breast implant placed after cancer surgery, surgical mesh is often used to support the implant and improve results. OviTex is a newer option and this study aims to gather real-world data on its safety, complication rates, and patient satisfaction outcomes. Women aged 18 to 75 who underwent implant-based breast reconstruction using a specific OviTex PRS product are eligible. Women who received a textured permanent breast implant, were nicotine users within four weeks of surgery, or had prior radiation therapy to the chest wall are excluded. For the prospective portion, participants must be able to return for follow-up visits. For retrospective participants, data is collected from existing medical records. Prospective participants attend follow-up visits and may have photographs taken. No experimental treatment is involved. This study is important because choosing the right mesh material in breast reconstruction affects complication rates (including infection and implant failure) and long-term cosmetic outcomes — and real-world evidence helps surgeons and patients make better-informed decisions.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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.


Locations(11)

Aesthetic Surgery Center

Naples, Florida, United States

Castrellon Aesthetic Surgery

South Miami, Florida, United States

Y Plastic Surgery

Alpharetta, Georgia, United States

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

Houston Methodist The Woodlands Hospital

The Woodlands, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05736848


Related Trials