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

NCT ID: NCT01914653

Last Updated: 2017-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2016-03-31

Brief Summary

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.

Conditions

Breast Reconstruction

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pre-radiated

Group Type: EXPERIMENTAL

Silk surgical mesh

Intervention Type: DEVICE

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

Not radiated

Group Type: EXPERIMENTAL

Silk surgical mesh

Intervention Type: DEVICE

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

Post-radiated

Group Type: EXPERIMENTAL

Silk surgical mesh

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sofregen Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Allergan Medical

Locations

Assuta Medical Center

Tel Aviv, , Israel

Countries

Israel

Other Identifiers

SURE-006

Identifier Type: -

Identifier Source: org_study_id