Clinical trial NCT04646057: DuraSorb® in Prosthetic Breast Reconstruction
Official title: The Safety and Effectiveness of DuraSorb® for Reinforcement in Patients Undergoing Prosthetic Breast Reconstruction
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Reconstruction
Lead sponsor: Surgical Innovation Associates, Inc.
Sponsor class: INDUSTRY
First posted: 2020-11-27
Enrollment: 168
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite Clinical Success (CCS)
timeFrame: 12 Month Follow-Up
measure: Local Complications of Breast Reconstruction
timeFrame: 12 Month Follow-Up
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Specialists Plastic Surgery
state: Illinois
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Evanston
country: United States
facility: NorthShore University Health System
state: Illinois
city: Boston
country: United States
facility: Harvard Brigham and Women's Faulkner Hospital
state: Massachusetts
city: New York
country: United States
facility: NYU Grossman School of Medicine
state: New York
city: Houston
country: United States
facility: Kelsey-Seybold Clinic
state: Texas
city: Madison
country: United States
facility: University of Wisconsin Health University Hospital
state: Wisconsin
Study officials:
References: