Status:
COMPLETED
SERI® Surgical Scaffold Postmarket Study of Soft Tissue Support and Repair in Breast Reconstruction
Lead Sponsor:
Sofregen Medical, Inc.
Conditions:
Breast Reconstruction
Eligibility:
FEMALE
18+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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:
- 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
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01914653
Start Date
June 1 2013
End Date
March 1 2016
Last Update
October 9 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Assuta Medical Center
Tel Aviv, Israel