The SeriScaffold® Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery in Europe

Study Overview
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Brief Summary
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This is a post-market study of the use of SeriScaffold® for soft tissue support and repair in breast reconstruction surgery.

Conditions
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Soft Tissue Support and Repair

Intervention / Treatment
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* Device: SeriScaffold® Surgical Scaffold


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be female, greater or equal to 18 years of age Be willing to undergo immediate breast reconstruction with sub-pectoralis muscle placement of a breast implant 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: 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 any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability 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 |
| --- | --- |
| Experimental: SeriScaffold® Surgical Scaffold<br>Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold. | Device: SeriScaffold® Surgical Scaffold<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 |
| --- | --- | --- |
| Investigator Satisfaction With Seri® Surgical Scaffold on an 11-Point Scale | Investigator satisfaction after stage I surgery/implantation of SERI® Surgical Scaffold is evaluated on an 11-point scale, where 0=very dissatisfied to 10=very satisfied. | Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator Satisfaction With Seri® Surgical Scaffold on an 11-Point Scale | Investigator satisfaction after stage I surgery/implantation of SERI® Surgical Scaffold is evaluated on an 11-point scale, where 0=very dissatisfied to 10=very satisfied. | Month 3, Month 12, Month 18, Month 24 | 
| Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale | Investigator assessment of ease of use of SERI® Surgical Scaffold is evaluated on a 5-point scale, where 1=very difficult to use to 5=very easy to use. | Immediately Following Stage 1 Surgery | 
| Breast Anatomy Measurements | Breast anatomy measurements were taken at the following points: sternal notch to apex, sternal notch to inframammary fold, apex to inframammary fold, and medial mammary fold to lateral mammary fold. | Preoperative, First Postoperative, Month 3, Month 6, Month 12, Month 18, Month 24 | 
| Subject Satisfaction With Breasts on a 5-Point Scale | Subject satisfaction with breasts is evaluated on a 5-point scale, where 1=very dissatisfied to 5=very satisfied. | Baseline, Month 6, Month 12, Month 18, Month 24 |