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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01389232
Recruitment Status : Completed
First Posted : July 8, 2011
Last Update Posted : May 12, 2015
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Soft Tissue Support and Repair Device: SeriScaffold® Surgical Scaffold Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2011
Actual Primary Completion Date : August 2013
Actual Study Completion Date : February 2015

Arm Intervention/treatment
Experimental: 1
SeriScaffold® Surgical Scaffold
Device: SeriScaffold® Surgical Scaffold
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 Outcome Measures :
  1. Investigator satisfaction following use of SeriScaffold® surgical scaffold evaluated using an 11-point scale questionnaire [ Time Frame: Six months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01389232

Dusseldorf, Germany
Milan, Italy
Barcelona, Spain
United Kingdom
Nottingham, United Kingdom
Sponsors and Collaborators

Responsible Party: Allergan Identifier: NCT01389232     History of Changes
Other Study ID Numbers: SURE-002
First Posted: July 8, 2011    Key Record Dates
Last Update Posted: May 12, 2015
Last Verified: April 2015