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 ( Allergan Medical )
ClinicalTrials.gov Identifier:
NCT01389232
First received: July 6, 2011
Last updated: October 3, 2014
Last verified: October 2014
  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: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: June 2011
Estimated Study Completion Date: June 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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01389232

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

No publications provided

Responsible Party: Allergan ( Allergan Medical )
ClinicalTrials.gov Identifier: NCT01389232     History of Changes
Other Study ID Numbers: SURE-002
Study First Received: July 6, 2011
Last Updated: October 3, 2014
Health Authority: Spain: Ethics Committee

ClinicalTrials.gov processed this record on October 22, 2014