The SERI® Surgical Scaffold Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery

Study Overview
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Brief Summary
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The purpose of the study is to obtain clinical experience with the use of SERI® Surgical Scaffold for tissue support and repair in breast reconstruction.

Conditions
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Breast Reconstruction

Intervention / Treatment
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* Device: SERI® Surgical Scaffold


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be eligible for enrollment, the subject must: Be female, greater or equal to 18 years of age Be willing to undergo breast reconstruction with sub-pectoralis muscle placement of a tissue expander, followed by exchange with a sub-pectoral breast implant Have previously had or be willing to undergo mastectomy with healthy, well-vascularized skin flaps anticipated by the surgeon Be in good health other than breast pathology and be suited to general anesthesia and planned treatments. Exclusion Criteria: The subject must not: Have undergone breast radiation treatment and/or is preoperatively evaluated to require radiation treatment to the breast area during the course of the study Have a known allergy to silk Have collagen-vascular, connective disease, or bleeding disorders Have a Body Mass Index (BMI) that is greater than or equal to 35 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 other than any other current treatment for breast cancer Have smoked within the last 12 months 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 Have an abscess or infection at the time of surgery Have undergone previous breast surgery with the exception of mastectomy, breast biopsy, cyst removal, lumpectomy, mastopexy, reduction and/or augmentation Have had a prior soft tissue support device implanted in the breast Have a condition or be in a situation that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Implanted Participants<br>Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold. | Device: SERI® Surgical Scaffold<br>* Breast reconstruction surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator Satisfaction Following Use of SERI® Surgical Scaffold at 6 Months | The primary outcome measure was investigator satisfaction at 6 months after stage I surgery/implantation of SERI® Surgical Scaffold. Satisfaction was evaluated using an 11-point scale, where 0=very dissatisfied to 10=very satisfied. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator Ease of Use Assessment at the Time of SERI® Placement During Stage I Surgery | Ease of Use assessments of SERI® Surgical Scaffold by the investigator were collected on Case Report Forms (CRFs) following stage I surgery. Ease of Use was assessed separately using a 5-point scale, where 0=very difficult to 5=very easy to use for the following criteria: • SERI® preparation before implantation (excluding cutting or shaping) • SERI® cutting and shaping before implantation • SERI® positioning/drapability during implantation • SERI® cutting and shaping after implantation • SERI® suturing during implantation (including tension and stretch). The number of participants who were implanted with SERI® Surgical Scaffold (n=139) by Investigator Ease of Use response for each category is reported. | Immediately following Stage I surgery | 
| Investigator Satisfaction Following Use of SERI® Surgical Scaffold at Other Time Points | Investigator satisfaction with SERI® Surgical Scaffold was evaluated at Stage II surgery and Months 12, 18 and 24 after surgery/implantation using an 11-point scale, where 0=very dissatisfied to 10=very satisfied. | Stage 2 Surgery, Months 12, 18 and 24 |