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

Breast Reconstruction Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01914653
• Other study ID #: SURE-006
• Status: Completed
• Phase: N/A
• First received: July 31, 2013
• Last updated: October 5, 2017
• Start date: June 2013
• Est. completion date: March 2016

Study information

• Verified date: October 2017
• Source: Sofregen Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Reconstruction

Intervention

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

Locations

Country	Name	City	State
Israel	Assuta Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Sofregen Medical, Inc.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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