The SERI® Surgical Scaffold Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery

Sofregen Medical

Status

Completed

Conditions

Breast Reconstruction

Treatments

Device: SERI® Surgical Scaffold

Study type

Interventional

Funder types

Industry

Identifiers

NCT01256502

SURE-001

Details and patient eligibility

About

The purpose of the study is to obtain clinical experience with the use of SERI® Surgical Scaffold for tissue support and repair in breast reconstruction.

Enrollment

160 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

To be eligible for enrollment, the subject must:

Be female, greater or equal to 18 years of age
Be willing to undergo breast reconstruction with sub-pectoralis muscle placement of a tissue expander, followed by exchange with a sub-pectoral breast implant
Have previously had or be willing to undergo mastectomy with healthy, well-vascularized skin flaps anticipated by the surgeon
Be in good health other than breast pathology and be suited to general anesthesia and planned treatments.

Exclusion criteria

The subject must not:

Have undergone breast radiation treatment and/or is preoperatively evaluated to require radiation treatment to the breast area during the course of the study
Have a known allergy to silk
Have collagen-vascular, connective disease, or bleeding disorders
Have a Body Mass Index (BMI) that is greater than or equal to 35
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 other than any other current treatment for breast cancer
Have smoked within the last 12 months
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
Have an abscess or infection at the time of surgery
Have undergone previous breast surgery with the exception of mastectomy, breast biopsy, cyst removal, lumpectomy, mastopexy, reduction and/or augmentation
Have had a prior soft tissue support device implanted in the breast
Have a condition or be in a situation that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.