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

This study is enrolling participants by invitation only.

Sponsor:

Information provided by (Responsible Party):

Allergan Medical

ClinicalTrials.gov Identifier:

NCT01389232

First received: July 6, 2011

Last updated: December 12, 2012

Last verified: December 2012

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:

U.S. FDA Resources

Further study details as provided by Allergan Medical:

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 ]

Estimated Enrollment:	100
Study Start Date:	June 2011
Estimated Study Completion Date:	April 2015
Estimated Primary Completion Date:	October 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 Other Name: SeriScaffold®

Eligibility

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

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

Locations

Sponsors and Collaborators

Allergan Medical

More Information

No publications provided

Responsible Party:	Allergan Medical
ClinicalTrials.gov Identifier:	NCT01389232 History of Changes
Other Study ID Numbers:	CLN-SCFLD-001
Study First Received:	July 6, 2011
Last Updated:	December 12, 2012
Health Authority:	Spain: Ethics Committee

ClinicalTrials.gov processed this record on May 19, 2013