DuraSorb® in Prosthetic Breast Reconstruction

NCT04646057 | Unknown DMC FDA Device

• 1 other identifier: 19-004
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Breast Reconstruction

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Treatment Arm

EXPERIMENTAL

Device: DuraSorb®

Historical Control Arm

NO INTERVENTION

Interventions

DuraSorb® DEVICE

Monofilament Surgical Mesh

Treatment Arm

Eligibility Criteria

• Age: 22 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Surgical Innovation Associates, Inc.: lead

Study Sites (7)

Northwestern Specialists Plastic Surgery

Chicago, Illinois, 60611, United States

Location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

NorthShore University Health System

Evanston, Illinois, 60201, United States

Location

Harvard Brigham and Women's Faulkner Hospital

Boston, Massachusetts, 02130, United States

Location

NYU Grossman School of Medicine

New York, New York, 10017, United States

Location

Kelsey-Seybold Clinic

Houston, Texas, 70725, United States

Location

University of Wisconsin Health University Hospital

Madison, Wisconsin, 53792, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: November 27, 2020
• Study Start: January 15, 2021
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 18, 2024

Record last verified: 2023-11

Locations

US (7)