MastectomyPhase 4NCT00616824
The Use of an Acellular Dermal Matrix in a Two-Staged Breast Reconstruction
A Phase 4 study testing Dermamatrix to cover lateral aspect of tissue expander and Serratus anterior to cover lateral aspect of tissue expander in people with Mastectomy and Postoperative Pain, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
This study intends to compare postoperative outcomes of a tissue expander placement following a mastectomy with two different operative techniques. This study will be randomized and double blinded comparing the traditional placement of the tissue expander under an inferolateral serratus muscle flap to a new technique… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Mastectomy, Postoperative Pain, Complications
- What is being tested?
- Dermamatrix to cover lateral aspect of tissue expander and Serratus anterior to cover lateral aspect of tissue expander
- 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
- Sep 2007to Mar 2010
- Phase
- Phase 4
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting to Dr. Wendel's clinic who are older than 17 years of age undergoing a mastectomy and wish to have breast reconstruction with a tissue expander or those who have previously undergone a mastectomy and are now seeking reconstruction will be solicited for the study.
Who cannot join
- Preoperative radiation therapy
- Autoimmune disease
- Fever
- Uncontrolled diabetes mellitus
- Inability to comprehend or cooperate with postoperative instructions
- Local or systemic infection
Show all 12Show fewer
- Have any allergies to the excipient ingredients found in the matrix
- Pregnancy
- Low vascularity of the surrounding tissue
- Mechanical trauma
- Poor nutrition
- Poor general medical condition
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-2345
About this study
Official title: The Use of an Acellular Dermal Matrix in a Two-Staged Breast Reconstruction The Use of an Acellular Dermal Matrix in a Two-Staged Breast Reconstruction After Mastectomy: A Double-Blinded, Randomized Trial
This study intends to compare postoperative outcomes of a tissue expander placement following a mastectomy with two different operative techniques. This study will be randomized and double blinded comparing the traditional placement of the tissue expander under an inferolateral serratus muscle flap to a new technique which uses an acellular dermal matrix as an inferolateral sling, instead of the muscle flap.
The study we are proposing will evaluate the question of whether there is a difference between the traditional method of serratus flap and the new technique of using an acellular matrix with tissue expander placement. This will be a double blinded randomized study of thirty women in each group comparing outcomes which will include postoperative pain, complications (wound infection, hematoma, capsular contracture, etc), and patient satisfaction with the procedure.
- Conditions
- Mastectomy, Postoperative Pain, Complications
- Being tested
- Dermamatrix to cover lateral aspect of tissue expander, Serratus anterior to cover lateral aspect of tissue expander
- Keywords
- Acellular dermal matrix, breast reconstruction, tissue expander, postoperative pain, complication, pain, patient satisfaction
- Medical subject headings
- Pain, Postoperative, Pain, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dermamatrix to cover lateral aspect of tissue expanderProcedure or surgery
Also called Dermamatrix
Dermamatrix used to cover lateral aspect of breast tissue expander after mastectomy
Serratus anterior to cover lateral aspect of tissue expanderProcedure or surgery
Traditional use of serratus anterior for coverage of lateral aspect of tissue expander
| Study group | Role | What they receive |
|---|---|---|
| Traditional Method | Active comparator | Arm which uses the Serratus Anterior muscle mobilization for lateral coverage of the tissue expander Receives: Procedure: Serratus anterior to cover lateral aspect of tissue expander |
| Dermamatrix Arm | Experimental | Arm which uses Dermamatrix as the lateral expander coverage Receives: Procedure: Dermamatrix to cover lateral aspect of tissue expander |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
Measured: perioperative up to 1 year
Secondary outcomes (3)
aesthetic outcome
Measured: 1 year
complications (infection, hematoma, capsular contracture)
Measured: 1 year
Patient satisfaction
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startSep 2007
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MastectomyStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason J. Wendel, M.D., Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00616824
- Sponsor's protocol ID
- 070415
- Other IDs
- 070415
- Status last verified
- Mar 2017
- First submitted
- 5 Feb 2008
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of an Acellular Dermal Matrix in a Two-Staged Breast Reconstruction The Use of an Acellular Dermal Matrix in a Two-Staged Breast Reconstruction After Mastectomy: A Double-Blinded, Randomized Trial
- ClinicalTrials.gov ID
- NCT00616824
- Acronym / sponsor ID
- 070415
- Conditions
- Mastectomy, Postoperative Pain, Complications
- Keywords
- Acellular dermal matrix, breast reconstruction, tissue expander, postoperative pain, complication, pain, patient satisfaction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 15 Feb 2008 (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.
This study intends to compare postoperative outcomes of a tissue expander placement following a mastectomy with two different operative techniques. This study will be randomized and double blinded comparing the traditional placement of the tissue expander under an inferolateral serratus muscle flap to a new technique which uses an acellular dermal matrix as an inferolateral sling, instead of the muscle flap.
The study we are proposing will evaluate the question of whether there is a difference between the traditional method of serratus flap and the new technique of using an acellular matrix with tissue expander placement. This will be a double blinded randomized study of thirty women in each group comparing outcomes which will include postoperative pain, complications (wound infection, hematoma, capsular contracture, etc), and patient satisfaction with the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Method | Active comparator | Procedure: Serratus anterior to cover lateral aspect of tissue expanderArm which uses the Serratus Anterior muscle mobilization for lateral coverage of the tissue expander |
| Dermamatrix Arm | Experimental | Procedure: Dermamatrix to cover lateral aspect of tissue expanderArm which uses Dermamatrix as the lateral expander coverage |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients presenting to Dr. Wendel's clinic who are older than 17 years of age undergoing a mastectomy and wish to have breast reconstruction with a tissue expander or those who have previously undergone a mastectomy and are now seeking reconstruction will be solicited for the study.
Key exclusion criteria (12 listed)
- Preoperative radiation therapy
- Autoimmune disease
- Fever
- Uncontrolled diabetes mellitus
- Inability to comprehend or cooperate with postoperative instructions
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 |
|---|---|---|
| Dermamatrix to cover lateral aspect of tissue expanderAlso: DermamatrixDermamatrix used to cover lateral aspect of breast tissue expander after mastectomy | Procedure or surgery | Dermamatrix Arm |
| Serratus anterior to cover lateral aspect of tissue expanderTraditional use of serratus anterior for coverage of lateral aspect of tissue expander | Procedure or surgery | Traditional Method |
Primary outcome
postoperative pain
Time frame: perioperative up to 1 year
3 secondary outcomes
aesthetic outcome
Time frame: 1 year
complications (infection, hematoma, capsular contracture)
Time frame: 1 year
Patient satisfaction
Time frame: 1 year
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 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.
Jason J. Wendel, M.D. principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dermamatrix to cover lateral aspect of tissue expander and Serratus anterior to cover lateral aspect of tissue expander in people with Mastectomy and Postoperative Pain, run by Vanderbilt University Medical Center 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 12 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 4 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
postoperative pain (time frame: perioperative up to 1 year). 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 4 Apr 2017.