OviTex PRS for immediate implant-based breast reconstruction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study implants the OviTex PRS mesh as part of first-time, immediate direct-to-implant (DTI) pre-pectoral breast reconstruction following mastectomy. Eligible participants are adult women scheduled for unilateral or bilateral reconstruction who meet BMI and smoking-status criteria and consent to follow-up visits, questionnaires, clinic exams, and standardized photographs. Outcomes will include measures of safety (complications, adverse events) and clinical performance related to implant support and wound healing over the postoperative follow-up period. Data collection will be performed at a single investigational site with protocol-driven visits and documentation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patient is a female between the ages of 22 - 75, inclusive, at the time of enrollment (e.g. date of index surgical procedure);
2. Patient is planned for a first-time immediate unilateral or bilateral DTI pre-pectoral breast reconstruction following mastectomy for cancer or as cancer prophylaxis;
3. Patient is not a current cigarette smoker;
4. Patient is willing and able to voluntarily sign the IRB approved Subject Informed Consent Form;
5. Patient is willing and able to comply with the study requirements including completion of required follow-up visits, subject questionnaires, clinic evaluations, and photographs.

Exclusion Criteria:

1. Patient has a BMI \< 18.5 or \> 35;
2. Patient is undergoing radical mastectomy;
3. Breast reconstruction plan includes hybrid implant coverage using another type of mesh (synthetic or ADM) or another autologous treatment such as large latissimus flap, abdominal flap or similar;
4. Breast reconstruction plan includes a custom sized breast implant, permanent breast implant greater than 800cc, and/or a permanent breast implant that is not FDA approved for use in breast reconstruction;
5. Patient has undergone prior breast reconstruction, breast augmentation, mastopexy, or breast reduction surgeries (not including breast biopsy);
6. Patient is undergoing delayed reconstruction;
7. Patient has received neo-adjuvant radiation to the chest (including any previous history of whole breast radiation or mantle radiation);
8. Patient has received neo-adjuvant chemotherapy within the 4 weeks prior to enrollment;
9. Patient has received Keytruda therapy or is planning to receive Keytruda therapy during study participation;
10. Patient has uncontrolled Type I or Type II diabetes (HbA1C \>7%);
11. Patient is pregnant or planning to become pregnant during study participation and up to 5 years from the index surgical procedure;

    • If the subject is not post-menopausal, agree to take adequate birth control precautions during study participation;
12. Patient has been diagnosed with a medical condition or is taking medications which are known to impact wound healing, weaken the body's natural resistance to disease, result in elevated postoperative risks, or may otherwise affect the validity of the study;
13. Patient has a known sensitivity or allergy to poly(lactic-co-glycolic acid) (PLGA) or materials of ovine (sheep) origin;
14. Patient is diagnosed with a bleeding disorder in which medication is not stopped within 2 weeks of the index procedure;
15. Patient is currently diagnosed with drug or alcohol abuse or has a known history with relapse within the past 3 years;
16. Patient is currently participating in another drug or device clinical trial;
17. Patient is currently imprisoned.

Intraoperative Exclusion Criteria

All subjects will be evaluated intraoperatively for the following exclusion criteria:

1. Subject does not receive an immediate pre-pectoral direct-to-implant breast reconstruction;
2. Study device will not be used during the procedure or a non-eligible device will be implanted.

Where it's running

• University of South Florida Plastic Surgery
  Tampa, Florida, United States Recruiting
• Qualmedica Research
  Bowling Green, Kentucky, United States Recruiting
• WakeMed
  Raleigh, North Carolina, United States Recruiting

Study contacts

• Study coordinator: Senior Clinical Project Manager
• Email: telaclinicalresearch@telabio.com
• Phone: 484-320-2930

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.