DuraSorb® in Prosthetic Breast Reconstruction

Breast Reconstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04646057
• Other study ID #: 19-004
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 15, 2021
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: Surgical Innovation Associates, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 168
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 22 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Reconstruction

Intervention

Device:
• DuraSorb®
Monofilament Surgical Mesh

Locations

Country	Name	City	State
United States	Harvard Brigham and Women's Faulkner Hospital	Boston	Massachusetts
United States	Northwestern Specialists Plastic Surgery	Chicago	Illinois
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois
United States	NorthShore University Health System	Evanston	Illinois
United States	Kelsey-Seybold Clinic	Houston	Texas
United States	University of Wisconsin Health University Hospital	Madison	Wisconsin
United States	NYU Grossman School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Surgical Innovation Associates, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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