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Active, not recruitingNCT04646057Updated Apr 18, 2024

DuraSorb® in Prosthetic Breast Reconstruction

An interventional study of DuraSorb® in Breast Reconstruction, sponsored by Surgical Innovation Associates, Inc.. Active, not recruiting at 7 sites in United States. Open to female participants aged 22 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-04-18.

Sponsored by Surgical Innovation Associates, Inc. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 4 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
168
Allocation
Non-randomized
Ages
22 Years to 70 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Breast Reconstruction
03

In context

Lead sponsor

This is the only study on the registry with Surgical Innovation Associates, Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
168 participants (actual)

Study arms

  • Experimental
    Treatment Arm

    Device: DuraSorb®

  • No intervention
    Historical Control Arm

Interventions

  • DeviceDuraSorb®

    Monofilament Surgical Mesh

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 Month Follow-Up

  2. 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.

    Time frame: 12 Month Follow-Up

07

Study locations

7 sites
  • Northwestern Specialists Plastic Surgery
    Chicago, Illinois 60611, United States
  • Northwestern University Feinberg School of Medicine
    Chicago, Illinois 60611, United States
  • NorthShore University Health System
    Evanston, Illinois 60201, United States
  • Harvard Brigham and Women's Faulkner Hospital
    Boston, Massachusetts 02130, United States
  • NYU Grossman School of Medicine
    New York, New York 10017, United States
  • Kelsey-Seybold Clinic
    Houston, Texas 70725, United States
  • University of Wisconsin Health University Hospital
    Madison, Wisconsin 53792, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04646057
Lead sponsor
Surgical Innovation Associates, Inc.
Responsible party
Sponsor
First posted
Nov 27, 2020
Start date
Jan 15, 2021
Primary completion
Jun 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
Apr 18, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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