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

Condition Intervention
Soft Tissue Support and Repair Device: SeriScaffold® Surgical Scaffold

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Investigator satisfaction following use of SeriScaffold® surgical scaffold evaluated using an 11-point scale questionnaire [ Time Frame: Six months ]

Enrollment: 100
Study Start Date: June 2011
Study Completion Date: February 2015
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01389232


Locations
Germany
Dusseldorf, Germany
Italy
Milan, Italy
Spain
Barcelona, Spain
United Kingdom
Nottingham, United Kingdom
Sponsors and Collaborators
Allergan
  More Information

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01389232     History of Changes
Other Study ID Numbers: SURE-002
First Submitted: July 6, 2011
First Posted: July 8, 2011
Last Update Posted: October 12, 2017
Last Verified: April 2015