DuraSorb® in Prosthetic Breast Reconstruction

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

Detailed Description
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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.

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

Conditions
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Breast Reconstruction

Intervention / Treatment
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* Device: DuraSorb®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm<br> | Device: DuraSorb®<br>* Monofilament Surgical Mesh<br>|
| No Intervention: Historical Control Arm<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BREAST-Q PRO |  | 12 Month Follow-Up | 
| Local Complications of Breast Reconstruction |  | 12 Month Follow-Up |