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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01389232
First Posted: July 8, 2011
Last Update Posted: October 12, 2017
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.
Information provided by (Responsible Party):
Allergan
July 6, 2011
July 8, 2011
October 12, 2017
June 2011
August 2013   (Final data collection date for primary outcome measure)
Investigator satisfaction following use of SeriScaffold® surgical scaffold evaluated using an 11-point scale questionnaire [ Time Frame: Six months ]
Same as current
Complete list of historical versions of study NCT01389232 on ClinicalTrials.gov Archive Site
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The SeriScaffold® Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery in Europe
Not Provided
This is a post-market study of the use of SeriScaffold® for soft tissue support and repair in breast reconstruction surgery.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Soft Tissue Support and Repair
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
Experimental: 1
SeriScaffold® Surgical Scaffold
Intervention: Device: SeriScaffold® Surgical Scaffold
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
February 2015
August 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Italy,   Spain,   United Kingdom
 
 
NCT01389232
SURE-002
Not Provided
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Allergan
Allergan
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Not Provided
Allergan
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP