SERI® Surgical Scaffold Postmarket Study of Soft Tissue Support and Repair in Breast Reconstruction

Study Overview
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Brief Summary
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Prospective, single center, postmarket clinical study to obtain clinical experience with the use of SERI® Surgical Scaffold for soft tissue support and repair in breast reconstruction.

Conditions
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Breast Reconstruction

Intervention / Treatment
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* Device: Silk surgical mesh


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be eligible for enrollment, the subject must: Be female, ≥ 18 years of age If the subject is a female of childbearing potential, have a pregnancy test evaluated as negative prior to surgery, per the site's standard of care Have a nicotine test evaluated as negative prior to surgery and agree not to smoke for the duration of the study Be willing to undergo mastectomy with healthy, well-vascularized skin flaps anticipated by the surgeon Be eligible to enroll in one of the following three cohorts: 1. Subject had radiation therapy (XRT) prior to direct-to-implant (DTI) reconstruction, but will not have XRT following reconstruction; 2. Subject did not have XRT prior to DTI reconstruction and will not have XRT following reconstruction; 3. Subject did not have XRT prior to DTI reconstruction, but will have XRT following reconstruction. Exclusion Criteria: To be eligible for enrollment, the subject must not: Have collagen-vascular, connective tissue, or bleeding disorders Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability Have an autoimmune disease, an immune deficiency, or is on immune-suppression drugs for reasons other than current treatment for breast cancer Have a BMI that is ≥ 32 Have a nicotine test evaluated as positive prior to surgery or unwilling to quit smoking for the duration of the study Currently have an alcohol/substance abuse problem or have had a relapse within 1 year prior to screening visit Be pregnant, lactating, or expecting to be within the next 24 months Have concomitant unrelated condition of breast/chest wall/skin (e.g. significant chest wall abnormalities including pectus excavatum or pectus carinatum) Require the use of any additional implant for soft tissue support of the contralateral non-study breast, except in bilateral breast reconstructions, where the use of SERI® Surgical Scaffold is allowed Have had a prior soft tissue support implant If enrolled into the Pre-Radiated cohort, have had recent radiation (< 1 year) to the breast/chest wall If enrolled into the Post-Radiated cohort, radiation to the breast/chest wall is planned more than 1 year from the time of SERI® Surgical Scaffold placement Have clinical evidence of severe radiation tissue damage (e.g. pigmentation, indentation, atrophy, no elasticity to skin of radiated breast) from previous XRT to the breast/chest wall Have large or multiple scars on the breast(s) that may interfere with blood supply to the mastectomy flaps

Ages Eligible for Study
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Minimum Age: 18 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pre-radiated<br> | Device: Silk surgical mesh<br>* A CE Marked, 510(k) cleared, knitted, multi-filament, bioengineered, silk mesh indicated for use as a transitory scaffold for soft tissue support and repair<br>|
| Experimental: Not radiated<br> | Device: Silk surgical mesh<br>* A CE Marked, 510(k) cleared, knitted, multi-filament, bioengineered, silk mesh indicated for use as a transitory scaffold for soft tissue support and repair<br>|
| Experimental: Post-radiated<br> | Device: Silk surgical mesh<br>* A CE Marked, 510(k) cleared, knitted, multi-filament, bioengineered, silk mesh indicated for use as a transitory scaffold for soft tissue support and repair<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Implant Loss | Implant Loss will be defined as situations in which the breast implant is removed and not immediately replaced. | 24 months postoperatively |