Using an antibacterial matrix device for 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 clinical trial evaluates the safety and effectiveness of an absorbable antibacterial matrix device in patients undergoing two-stage prepectoral alloplastic breast reconstruction following mastectomy. It is a prospective, multicenter, randomized, controlled trial designed to compare outcomes between those receiving the matrix device and those who do not. The study aims to assess how this device may improve surgical outcomes and reduce complications in breast reconstruction procedures.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Female.
* Age 22 or older at the time of enrollment.
* Is scheduled to undergo unilateral or bilateral mastectomy (including prophylactic) with immediate two-stage post-mastectomy alloplastic prepectoral breast reconstruction.
* Is able to and willing to comply with the study requirements and providing informed consent.

Exclusion Criteria:

* Has prior history of neoadjuvant radiotherapy.
* Has had prior history of failed tissue expansion or breast implantation at the intended reconstruction site.
* Has an active abscess or infection requiring antibiotics anywhere in their body within 30 days.
* Has a Body Mass Index (BMI) \< 14 or \> 40.
* Is pregnant or is nursing; or plans to become pregnant during the course of the study.
* Has any connective tissue/autoimmune disorder or rheumatoid disease.
* Has known allergies to study device materials.
* Is participating in another interventional research study that may interfere with study endpoints.
* Has limited life expectancy or co-morbid conditions, social/psychological problems, or cognitive impairments that precludes participation.
* Has a medical condition or is taking medications that would result in elevated risk and/or affect the validity of the study.
* Intraoperative assessment demonstrates unfavorable conditions (i.e., poor mastectomy skin flap thickness or viability) for immediate, two-stage post-mastectomy alloplastic prepectoral reconstruction in any breast.

Where it's running

• Stanford University
  Palo Alto, California, United States Recruiting
• University of Michigan Health
  Ann Arbor, Michigan, United States Recruiting
• Mayo Clinic
  Rochester, Minnesota, United States Recruiting
• Northwell Health
  Staten Island, New York, United States Recruiting
• The Ohio State University
  Columbus, Ohio, United States Recruiting
• Upmc
  Pittsburgh, Pennsylvania, United States Recruiting

Study contacts

• Study coordinator: Michele Hilmer
• Email: michele.hilmer@melodihealth.com
• Phone: 210-279-0194

Similar studies

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.