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

  • End date
    Aug 13, 2024
  • participants needed
  • sponsor
    Surgical Innovation Associates, Inc.
Updated on 13 October 2022


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


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.

Condition Breast Reconstruction
Treatment DuraSorb®
Clinical Study IdentifierNCT04646057
SponsorSurgical Innovation Associates, Inc.
Last Modified on13 October 2022


Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note