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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Allergan Medical
ClinicalTrials.gov Identifier:
NCT01914653
First received: July 31, 2013
Last updated: August 5, 2014
Last verified: August 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan Medical:

Primary Outcome Measures:
  • Incidence of Implant Loss [ Time Frame: 24 months postoperatively ] [ Designated as safety issue: Yes ]
    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
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pre-radiated
Women who have undergone radiation therapy prior to breast reconstruction and will not undergo radiation therapy after reconstruction.
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
Other Name: SERI® Surgical Scaffold
Experimental: Not radiated
Women who have not undergone radiation therapy prior to breast reconstruction and will not undergo radiation therapy after reconstruction
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
Other Name: SERI® Surgical Scaffold
Experimental: Post-radiated
Women who have not undergone radiation therapy prior to breast reconstruction and will undergo radiation therapy after reconstruction
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
Other Name: SERI® Surgical Scaffold

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01914653

Locations
Israel
Tel Aviv, Israel
Sponsors and Collaborators
Allergan Medical
Investigators
Study Director: Medical Director Allergan Medical
  More Information

No publications provided

Responsible Party: Allergan Medical
ClinicalTrials.gov Identifier: NCT01914653     History of Changes
Other Study ID Numbers: SURE-006
Study First Received: July 31, 2013
Last Updated: August 5, 2014
Health Authority: Israel: Ministry of Health

ClinicalTrials.gov processed this record on August 28, 2014