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

Not Applicable

Completed

• Conditions: Soft Tissue Support and Repair
• Interventions: Device: SeriScaffold® Surgical Scaffold

• Registration Number: NCT01389232
• Lead Sponsor: Sofregen Medical, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-07-06
• Study First Submitted QC: 2011-07-07
• Study First Posted: 2011-07-08
• Primary Completion: 2013-08
• Disposition First Submitted: 2014-08-22
• Disposition First Submitted QC: 2014-10-03
• Disposition First Posted: 2014-10-13
• Study Completion: 2015-02
• Results First Submitted: 2017-06-15
• Status Verified: 2021-05
• Results First Submitted QC: 2021-05-25
• Last Update Submitted: 2021-05-25
• Results First Posted: 2021-06-21
• Last Update Posted: 2021-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 104

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SeriScaffold® Surgical Scaffold	SeriScaffold® Surgical Scaffold	Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.

Primary Outcome Measures

Name	Time	Method
Investigator Satisfaction With Seri® Surgical Scaffold on an 11-Point Scale	Month 6	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.

Secondary Outcome Measures

Name	Time	Method
Breast Anatomy Measurements	Preoperative, First Postoperative, Month 3, Month 6, Month 12, Month 18, Month 24	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.
Investigator Satisfaction With Seri® Surgical Scaffold on an 11-Point Scale	Month 3, Month 12, Month 18, Month 24	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.
Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale	Immediately Following Stage 1 Surgery	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.
Subject Satisfaction With Breasts on a 5-Point Scale	Baseline, Month 6, Month 12, Month 18, Month 24	Subject satisfaction with breasts is evaluated on a 5-point scale, where 1=very dissatisfied to 5=very satisfied.