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

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

Study Overview

• Status: Completed
• Conditions: Soft Tissue Support and Repair
• Intervention / Treatment: Device: SeriScaffold® Surgical Scaffold

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Dusseldorf, Germany
  • Munich, Germany
• Italy
  • Milan, Italy
• Spain
  • Barcelona, Spain
• United Kingdom
  • Nottingham, United Kingdom

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SeriScaffold® Surgical Scaffold; Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.	Device: SeriScaffold® Surgical Scaffold; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sofregen Medical, Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: July 6, 2011
• First Submitted That Met QC Criteria: July 7, 2011
• First Posted (Estimate): July 8, 2011

Study Record Updates

• Last Update Posted (Actual): June 21, 2021
• Last Update Submitted That Met QC Criteria: May 25, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: SuRe-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No