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

NCT01914653 | Completed

• 1 other identifier: SURE-006
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Pre-radiated

EXPERIMENTAL

Device: Silk surgical mesh

Not radiated

EXPERIMENTAL

Device: Silk surgical mesh

Post-radiated

EXPERIMENTAL

Device: Silk surgical mesh

Interventions

Silk surgical mesh 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; Post-radiated; Pre-radiated

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be eligible for enrollment, the subject must:
• Be female, ≥ 18 years of age
• 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
• Have a nicotine test evaluated as negative prior to surgery and agree not to smoke for the duration of the study
• Be willing to undergo mastectomy with healthy, well-vascularized skin flaps anticipated by the surgeon
• Be eligible to enroll in one of the following three cohorts:
• \. Subject had radiation therapy (XRT) prior to direct-to-implant (DTI) reconstruction, but will not have XRT following reconstruction;
• \. Subject did not have XRT prior to DTI reconstruction and will not have XRT following reconstruction;
• \. Subject did not have XRT prior to DTI reconstruction, but will have XRT following reconstruction.

You may not qualify if:

• To be eligible for enrollment, the subject must not:
• Have collagen-vascular, connective tissue, or bleeding disorders
• Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability
• Have an autoimmune disease, an immune deficiency, or is on immune-suppression drugs for reasons other than current treatment for breast cancer
• Have a BMI that is ≥ 32
• Have a nicotine test evaluated as positive prior to surgery or unwilling to quit smoking for the duration of the study
• Currently have an alcohol/substance abuse problem or have had a relapse within 1 year prior to screening visit
• Be pregnant, lactating, or expecting to be within the next 24 months
• Have concomitant unrelated condition of breast/chest wall/skin (e.g. significant chest wall abnormalities including pectus excavatum or pectus carinatum)
• 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
• Have had a prior soft tissue support implant
• If enrolled into the Pre-Radiated cohort, have had recent radiation (\< 1 year) to the breast/chest wall
• 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
• 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
• Have large or multiple scars on the breast(s) that may interfere with blood supply to the mastectomy flaps

Sponsors & Collaborators

• Sofregen Medical, Inc.: lead

Study Sites (1)

Assuta Medical Center

Tel Aviv, Israel

Location

Study Officials

• Medical Director

  Allergan Medical

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2013
• First Posted: August 2, 2013
• Study Start: June 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: October 9, 2017

Record last verified: 2017-10

Locations

IL (1)