This trial is active, not recruiting.

Condition soft tissue support and repair
Treatment seriscaffold® surgical scaffold
Sponsor Allergan Medical
Start date June 2011
End date August 2013
Trial size 100 participants
Trial identifier NCT01389232, SURE-002


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
Primary purpose treatment
SeriScaffold® Surgical Scaffold
seriscaffold® surgical scaffold SeriScaffold®
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

Primary Outcomes

Investigator satisfaction following use of SeriScaffold® surgical scaffold evaluated using an 11-point scale questionnaire
time frame: Six months

Eligibility Criteria

Female participants at least 18 years old.

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

Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by Allergan Medical.