NCT04646057

DuraSorb® in Prosthetic Breast Reconstruction

The Safety and Effectiveness of DuraSorb® for Reinforcement in Patients Undergoing Prosthetic Breast Reconstruction

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: Surgical Innovation Associates, Inc. · Industry
• Sex: Female
• Age: 22 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study compares outcomes of prospective mesh-based breast reconstructions to historical control breast reconstructions with no mesh.

Detailed description

Plastic surgeons have a variety of biologic and synthetic mesh available for use. However, no mesh has adequately evaluated safety and effectiveness for FDA approval or clearance for use in breast reconstruction. Therefore, no mesh is an appropriate comparator for a randomized clinical study. This multi-center, prospective, clinical study with matched historical controls of total submuscular 2-stage breast reconstructions with no mesh will evaluate the safety and effectiveness of DuraSorb® monofilament surgical mesh when implanted in subjects undergoing 2-stage breast reconstruction. Women scheduled for mastectomy and immediate 2-stage breast reconstruction will sign informed consent and satisfy eligibility criteria prior to the first stage of surgery and DuraSorb® implantation. Maximum study follow-up is through one year after definitive reconstruction.

Conditions

• Breast Reconstruction

Interventions

Type	Name	Description
DEVICE	DuraSorb®	Monofilament Surgical Mesh

Timeline

• Start date: 2021-01-15
• Primary completion: 2024-06-01
• Completion: 2024-12-01
• First posted: 2020-11-27
• Last updated: 2024-04-18

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study