CClinicalTrials.gg
CompletedNCT01454713RAVEUpdated Apr 5, 2017

Retrospective Analysis of Veritas in Breast Reconstruction

An observational study in Seroma, Necrosis and Infection, sponsored by Baxter Healthcare Corporation. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-05.

Sponsored by Baxter Healthcare Corporation · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
54
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Seroma
  • Necrosis
  • Infection

Browse trials for

03

In context

Necrosis

477 studies on the registry are indexed under Necrosis; 54 are open to participants now.

This study's enrollment of 54 is below the median of 100 across 147 observational studies indexed under Necrosis.

Browse Necrosis studies →

Lead sponsor

Baxter Healthcare Corporation is the lead sponsor of 78 studies on the registry; 1 is open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
54 participants (actual)

Groups and cohorts

  • Veritas

    Breast reconstruction with Veritas

06

Study locations

3 sites
  • Mark M. Mofid, MD
    San Diego, California 92037, United States
  • Michael Meininger, MD
    Troy, Michigan 48084, United States
  • Martin Lacey, MD
    St. Paul, Minnesota 55101, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 5, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01454713
Lead sponsor
Baxter Healthcare Corporation
Collaborators
Synovis Surgical Innovations
Responsible party
Sponsor
First posted
Oct 19, 2011
Start date
Oct 2010
Primary completion
Oct 2011
Completion
Oct 2011
Last update
Apr 5, 2017

Study contacts

Mark M Mofid, MD
principal investigator · UCSD

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion