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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01914653
First Posted: August 2, 2013
Last Update Posted: October 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sofregen Medical, Inc.
  Purpose
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.

Condition Intervention
Breast Reconstruction Device: Silk surgical mesh

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Sofregen Medical, Inc.:

Primary Outcome Measures:
  • Incidence of Implant Loss [ Time Frame: 24 months postoperatively ]
    Implant Loss will be defined as situations in which the breast implant is removed and not immediately replaced.


Enrollment: 17
Study Start Date: June 2013
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01914653


Locations
Israel
Assuta Medical Center
Tel Aviv, Israel
Sponsors and Collaborators
Sofregen Medical, Inc.
Investigators
Study Director: Medical Director Allergan Medical
  More Information

Responsible Party: Sofregen Medical, Inc.
ClinicalTrials.gov Identifier: NCT01914653     History of Changes
Other Study ID Numbers: SURE-006
First Submitted: July 31, 2013
First Posted: August 2, 2013
Last Update Posted: October 9, 2017
Last Verified: October 2017