The SeriScaffold® Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery in Europe
This trial is active, not recruiting.
|Condition||soft tissue support and repair|
|Treatment||seriscaffold® surgical scaffold|
|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|
|Dusseldorf, Germany||not available||no longer recruiting|
|Milan, Italy||not available||no longer recruiting|
|Barcelona, Spain||not available||no longer recruiting|
|Nottingham, United Kingdom||not available||no longer recruiting|
|Intervention model||single group assignment|
Investigator satisfaction following use of SeriScaffold® surgical scaffold evaluated using an 11-point scale questionnaire
time frame: Six months
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
Call for more information