DuraSorb® in Prosthetic Breast Reconstruction

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Reconstruction
• Intervention / Treatment: Device: DuraSorb®

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.

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michele Hilmer; Phone Number: +1 (210) 279-0194; Email: mhilmer@sia.health
• Study Contact Backup: Name: Joshua G Vose, MD; Phone Number: +1 (872) 870-0524; Email: josh@sia.health

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Feinberg School of Medicine
    • Chicago, Illinois, United States, 60611
      • Northwestern Specialists Plastic Surgery
    • Evanston, Illinois, United States, 60201
      • NorthShore University Health System
  • Massachusetts
    • Boston, Massachusetts, United States, 02130
      • Harvard Brigham and Women's Faulkner Hospital
  • New York
    • New York, New York, United States, 10017
      • NYU Grossman School of Medicine
  • Texas
    • Houston, Texas, United States, 70725
      • Kelsey-Seybold Clinic
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Health University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Female between the inclusive ages of 22 and 70 at the time of initial expander surgery
• Scheduled to undergo either unilateral or bilateral mastectomy with immediate 2-stage breast reconstruction
• Is able to understand the study requirements and is willing to provide written informed consent
• Is willing and able to return for all scheduled study visits

Exclusion Criteria:

• Is pregnant or planning to become pregnant during study participation
• Has a history of failed tissue expansion or breast implantation at the intended reconstruction site
• has a residual gross tumor at the intended reconstruction site
• has been treated for a systemic infection or a local infection at the surgical site that the investigator determines will affect the safety of the subject during breast reconstruction and/or mesh use
• has, as determined by the investigator, unsuitable tissue integrity for immediate 2-stage breast reconstruction
• has undergone previous radiation therapy to the reconstruction site or chest wall
• is scheduled to undergo post-operative radiation therapy at the reconstruction site
• has a Body Mass Index (BMI) < 14 or > 44
• has used nicotine products within 90 days of screening
• is currently taking medications including non-NSAID anti-coagulants, immunosuppressants (including systemic steroids), or other medications determined by the investigator to place the subject at an increased risk of local complications of breast reconstruction
• has been diagnosed with a comorbid condition determined by the investigator to place the subject at an increased risk of complications
• has participated in any other clinical study that the investigator feels may interfere with this clinical study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm	Device: DuraSorb®; Monofilament Surgical Mesh
No Intervention: Historical Control Arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite Clinical Success (CCS)	This outcome measure is a combination of effectiveness and safety components. CCS is defined as intraoperative fill volume of at least 45% of the total expander size and the absence of expander or implant removal for cause or major cosmetic revision between the DuraSorb Treatment Arm and historical controls.	12 Month Follow-Up
Local Complications of Breast Reconstruction	The rates of a set of breast reconstruction complications (i.e. infection, serum, necrosis, etc.) will be measured between the DuraSorb Treatment Arm and historical controls.	12 Month Follow-Up

Collaborators and Investigators

• Sponsor: Surgical Innovation Associates, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2021
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: November 20, 2020
• First Submitted That Met QC Criteria: November 20, 2020
• First Posted (Actual): November 27, 2020

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 19-004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes