Breast CancerNCT00692692
Use of Dermal Matrix in Breast Reconstruction
A study testing DermaMatrix in people with Breast Cancer, run by Vanderbilt University at 1 site in United States.
Trial summary
We propose to evaluate the question of whether there is a significant difference between the traditional method of serratus flap tissue expander reconstruction and the acellular matrix method. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- DermaMatrix
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Dec 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All women who are candidates for breast reconstruction using tissue expanders after mastectomy
Who cannot join
- Other forms of breast reconstruction after mastectomy
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: The Use of An Acellular Dermal Matrix Sling in a Two-stage Breast REconstruciton After Mastectomy: A Double-blinded Randomized Trial
We propose to evaluate the question of whether there is a significant difference between the traditional method of serratus flap tissue expander reconstruction and the acellular matrix method.
Read the detailed description
We propose a double blinded, randomized study of 60 women comparing outcomes which will include postoperative pain, complication rates and aesthetic outcome as assessed by the patient and a plastic surgeon blinded to the method of reconstruction.
- Conditions
- Breast Cancer
- Being tested
- DermaMatrix, standard of care tissue expander breast reconstruction surgery after mastectomy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DermaMatrixProcedure or surgery
Also called tissue expander breast reconstruction after mastectomy
experimental group with DermaMatrix acellular dermis over tissue expanders in addition to skin/soft tissue and muscle to allow for more natural appearing breast and prevention of complications
standard of care tissue expander breast reconstruction surgery after mastectomyProcedure or surgery
Also called standard of care using skin/soft tissue and muscle coverage of tissue expander for breast reconstruction after mastectomy without acellular dermal matrix
standard of care using skin/soft tissue and muscle coverage of tissue expander for breast reconstruction after mastectomy without acellular dermal matrix
| Study group | Role | What they receive |
|---|---|---|
| DermaMatrix | Experimental | experimental group with DermaMatrix acellular dermis over tissue expanders in addition to skin/soft tissue and muscle to allow for more natural appearing breast and prevention of complications Receives: Procedure: DermaMatrix |
| Standard of care | Active comparator | standard of care using skin/soft tissue and muscle coverage of tissue expander for breast reconstruction after mastectomy without acellular dermal matrix Receives: Procedure: standard of care tissue expander breast reconstruction surgery after mastectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction With the Procedure
Measured: one year from time of operation
Post Surgical Infection
Number of participants with post surgical infection
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startJun 2007
- Primary completionDec 2010
- Study completionDec 2010
Why it stopped: higher rate of post-operative infection in the Dermal Matrix arm of the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason Wendel, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00692692
- Sponsor's protocol ID
- 070416
- Status last verified
- Mar 2018
- First submitted
- 4 Jun 2008
- Last updated
- 19 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of An Acellular Dermal Matrix Sling in a Two-stage Breast REconstruciton After Mastectomy: A Double-blinded Randomized Trial
- ClinicalTrials.gov ID
- NCT00692692
- Acronym / sponsor ID
- 070416
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: higher rate of post-operative infection in the Dermal Matrix arm of the study
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 6 Jun 2008 (estimated)
- Results
- Posted 11 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We propose to evaluate the question of whether there is a significant difference between the traditional method of serratus flap tissue expander reconstruction and the acellular matrix method.
Detailed description
We propose a double blinded, randomized study of 60 women comparing outcomes which will include postoperative pain, complication rates and aesthetic outcome as assessed by the patient and a plastic surgeon blinded to the method of reconstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DermaMatrix | Experimental | Procedure: DermaMatrixexperimental group with DermaMatrix acellular dermis over tissue expanders in addition to skin/soft tissue and muscle to allow for more natural appearing breast and prevention of complications |
| Standard of care | Active comparator | Procedure: standard of care tissue expander breast reconstruction surgery after mastectomystandard of care using skin/soft tissue and muscle coverage of tissue expander for breast reconstruction after mastectomy without acellular dermal matrix |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All women who are candidates for breast reconstruction using tissue expanders after mastectomy
Key exclusion criteria (1 listed)
- Other forms of breast reconstruction after mastectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DermaMatrixAlso: tissue expander breast reconstruction after mastectomyexperimental group with DermaMatrix acellular dermis over tissue expanders in addition to skin/soft tissue and muscle to allow for more natural appearing breast and prevention of complications | Procedure or surgery | DermaMatrix |
| standard of care tissue expander breast reconstruction surgery after mastectomyAlso: standard of care using skin/soft tissue and muscle coverage of tissue expander for breast reconstruction after mastectomy without acellular dermal matrixstandard of care using skin/soft tissue and muscle coverage of tissue expander for breast reconstruction after mastectomy without acellular dermal matrix | Procedure or surgery | Standard of care |
Primary outcome
Patient Satisfaction With the Procedure
Time frame: one year from time of operation
Post Surgical Infection
Time frame: 4 weeks
Number of participants with post surgical infection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jason Wendel, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DermaMatrix in people with Breast Cancer, run by Vanderbilt University at 1 site 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 19 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 11 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Patient Satisfaction With the Procedure (time frame: one year from time of operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 19 Mar 2018.