The SeriScaffold® Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery in Europe

Sofregen Medical

Status

Completed

Conditions

Soft Tissue Support and Repair

Treatments

Device: SeriScaffold® Surgical Scaffold

Study type

Interventional

Funder types

Industry

Identifiers

SURE-002

Details and patient eligibility

About

This is a post-market study of the use of SeriScaffold® for soft tissue support and repair in breast reconstruction surgery.

Enrollment

104 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Be female, greater or equal to 18 years of age
Be willing to undergo immediate breast reconstruction with sub-pectoralis muscle placement of a breast implant
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

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 any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability
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