Retrospective Analysis of Veritas in Breast Reconstruction | NCT01454713

Studies
Retrospective Analysis of Veritas in Breast Reconstruction

NCT01454713

Sponsor

Baxter Healthcare Corporation

Status

Completed

Last Update Posted

Apr 5, 2017Actual

Enrollment

54Actual

Phase

Not provided

Conditions

Seroma
Necrosis
Infection

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Oct 2011Actual

Completion Date

Oct 2011Actual

First Submitted Date

Oct 17, 2011

First Submission Date that Met QC Criteria

Oct 17, 2011

First Posted Date

Oct 19, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2017

Last Update Posted Date

Apr 5, 2017Actual

Name	Class
Synovis Surgical Innovations	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Retrospective data collection of the use of Veritas in breast reconstruction surgery

Detailed Description

This is a multi-center study to retrospectively collect data on the use of Veritas Collagen Matrix in breast reconstruction. Data will be collected on post-operative complications in immediate breast reconstruction and then be compared to literature reported post-operative complication rates associated with the use of acellular dermal matrix in immediate breast reconstruction.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

54Actual

Label	Type	Description	Intervention Names
Veritas		Breast reconstruction with Veritas

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 years or older
Patients who underwent mastectomy with immediate breast reconstruction using Veritas collagen matrix
Patients who underwent mastectomy with single stage procedures or two-stage procedures using Veritas collagen matrix

Exclusion Criteria:

Patients who underwent delayed breast reconstruction
Reconstruction with something other than Veritas collagen matrix
Breasts that were created with DIEP or TRAM procedures

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Consecutive patients who have undergone single-stage or two-stage breast reconstruction surgery with Veritas

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mark M Mofid, MD	UCSD	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mark M. Mofid, MD		San Diego	California	92037	United States
Michael Meininger, MD

Condition Browse Module

MeSH Terms

ID	Term
D049291	Seroma
D009336	Necrosis
D007239	Infections

Ancestor Terms

ID	Term
D007249	Inflammation
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided