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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Allergan Medical
ClinicalTrials.gov Identifier:
NCT01389232
First received: July 6, 2011
Last updated: December 17, 2013
Last verified: December 2013

July 6, 2011
December 17, 2013
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 ] [ Designated as safety issue: No ]
Investigator satisfaction following use of SeriScaffold™ surgical scaffold evaluated using an 11-point scale questionnaire [ Time Frame: Six months ] [ Designated as safety issue: No ]
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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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
Other Name: SeriScaffold®
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.
 
Active, not recruiting
100
June 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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Italy,   Spain,   United Kingdom
 
NCT01389232
SURE-002
Not Provided
Allergan Medical
Allergan Medical
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Not Provided
Allergan Medical
December 2013

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