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
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