SeromaRAVENCT01454713
Retrospective Analysis of Veritas in Breast Reconstruction
An observational study of Seroma and Necrosis, run by Baxter Healthcare Corporation at 3 sites in United States.
Trial summary
Retrospective data collection of the use of Veritas in breast reconstruction surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 54 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2010to Oct 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients who have undergone single-stage or two-stage breast reconstruction surgery with Veritas
Who may be able to join
- 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
Who cannot join
- Patients who underwent delayed breast reconstruction
- Reconstruction with something other than Veritas collagen matrix
- Breasts that were created with DIEP or TRAM procedures
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Martin Lacey, MD
Saint Paul, Minnesota, 55101
Mark M. Mofid, MD
San Diego, California, 92037
Michael Meininger, MD
Troy, Michigan, 48084
About this study
Official title: Retrospective Analysis of Veritas in Breast Reconstruction (RAVE)
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.
- Medical subject headings
- Seroma, Necrosis, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Veritas | Breast reconstruction with Veritas |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2011 (estimated)
- Study startOct 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SeromaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Synovis Surgical Innovations
- Responsible party
- Sponsor
- Investigators
- Mark M Mofid, MD, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01454713
- Sponsor's protocol ID
- 10-001
- Acronym
- RAVE
- Status last verified
- Apr 2017
- First submitted
- 17 Oct 2011
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Veritas in Breast Reconstruction (RAVE)
- ClinicalTrials.gov ID
- NCT01454713
- Acronym / sponsor ID
- RAVE / 10-001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Synovis Surgical Innovations
- Study start
- Oct 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 19 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Veritas | – | –Breast reconstruction with Veritas |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients who have undergone single-stage or two-stage breast reconstruction surgery with Veritas
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Patients who underwent delayed breast reconstruction
- Reconstruction with something other than Veritas collagen matrix
- Breasts that were created with DIEP or TRAM procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark M Mofid, MD principal investigator
UCSD
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Seroma and Necrosis, run by Baxter Healthcare Corporation at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2017.