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

  • STATUS
    Recruiting
  • End date
    Aug 13, 2024
  • participants needed
    180
  • sponsor
    Surgical Innovation Associates, Inc.
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Updated on 13 October 2022
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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.

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

Eligibility

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

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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.

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

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