Retrospective Analysis of Veritas in Breast Reconstruction

NCT ID: NCT01454713

Last Updated: 2017-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Seroma Necrosis Infection

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Veritas

Breast reconstruction with Veritas

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Synovis Surgical Innovations

INDUSTRY

Sponsor Role collaborator

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark M Mofid, MD

Role: PRINCIPAL_INVESTIGATOR

UCSD

Locations

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Mark M. Mofid, MD

San Diego, California, United States

Site Status

Michael Meininger, MD

Troy, Michigan, United States

Site Status

Martin Lacey, MD

Saint Paul, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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10-001

Identifier Type: -

Identifier Source: org_study_id

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