Restrata® for Breast Reconstruction
What You Need to Know Before You Apply
What is the purpose of this trial?
This prospective single-arm pilot study will evaluate the application of meshed 5 × 7 cm Restrata® sheets to the abdominal wall donor site following deep inferior epigastric perforator (DIEP) or abdominal wall autologous free tissue transfer in 20 eligible patients.
Who Is on the Research Team?
Justin Sacks, MD, MBA, FACS
Principal Investigator
Washington University School of Medicine
Are You a Good Fit for This Trial?
This trial is for adults having breast reconstruction surgery using tissue from their abdomen (DIEP or similar procedures). Participants must be eligible for this type of surgery and able to follow study instructions.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Restrata®
Trial Overview
The study tests a synthetic mesh sheet called Restrata®, placed on the abdominal wall where tissue was taken during breast reconstruction. All participants receive the mesh, and researchers will monitor healing and safety.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients undergoing standard of care deep inferior epigastric perforator (DIEP) or abdominal wall free tissue transfer procedure will have Restrata® sheets applied to the abdominal wall donor site following flap harvest. Patients will be followed for 12 months to assess outcomes.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
Acera Surgical, Inc.
Industry Sponsor
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