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

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.

Study Overview

• Status: Completed
• Conditions: Breast Reconstruction
• Intervention / Treatment: Device: Silk surgical mesh

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel
    • Assuta Medical Center

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:

To be eligible for enrollment, the subject must:

1. Be female, ≥ 18 years of age
2. 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
3. Have a nicotine test evaluated as negative prior to surgery and agree not to smoke for the duration of the study
4. Be willing to undergo mastectomy with healthy, well-vascularized skin flaps anticipated by the surgeon
5. 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:

1. Have collagen-vascular, connective tissue, or bleeding disorders
2. Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability
3. Have an autoimmune disease, an immune deficiency, or is on immune-suppression drugs for reasons other than current treatment for breast cancer
4. Have a BMI that is ≥ 32
5. Have a nicotine test evaluated as positive prior to surgery or unwilling to quit smoking for the duration of the study
6. Currently have an alcohol/substance abuse problem or have had a relapse within 1 year prior to screening visit
7. Be pregnant, lactating, or expecting to be within the next 24 months
8. Have concomitant unrelated condition of breast/chest wall/skin (e.g. significant chest wall abnormalities including pectus excavatum or pectus carinatum)
9. 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
10. Have had a prior soft tissue support implant
11. If enrolled into the Pre-Radiated cohort, have had recent radiation (< 1 year) to the breast/chest wall
12. 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
13. 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
14. Have large or multiple scars on the breast(s) that may interfere with blood supply to the mastectomy flaps

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pre-radiated	Device: Silk surgical mesh; 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
Experimental: Not radiated	Device: Silk surgical mesh; 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
Experimental: Post-radiated	Device: Silk surgical mesh; 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
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

Collaborators and Investigators

• Sponsor: Sofregen Medical, Inc.
• Investigators: Study Director: Medical Director, Allergan Medical

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: July 31, 2013
• First Submitted That Met QC Criteria: July 31, 2013
• First Posted (Estimate): August 2, 2013

Study Record Updates

• Last Update Posted (Actual): October 9, 2017
• Last Update Submitted That Met QC Criteria: October 5, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: SURE-006