Malignant Neoplasm of the BreastNCT01372917
Evaluating AlloMax in Immediate Expander-Based Breast Reconstruction Study
An observational study of Malignant Neoplasm of the Breast and Acquired Absence of the Breast, run by National Center for Plastic Surgery, Virginia at 1 site in United States.
Trial summary
The study is a prospective multi-centered cohort study designed to determine the safety and efficacy of AlloMax in immediate expander-based breast reconstruction. Specifically, the study is designed to determine if sterility of human acellular dermal matrix results in a lower incidence of infection and seroma. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Malignant Neoplasm of the Breast, Acquired Absence of the Breast
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Aug 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 25 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Breast cancer patients who opt for immediate breast reconstruction with tissue expanders from clinic.
Who may be able to join
- Patients having immediate breast reconstruction with tissue expanders
- Unilateral or bilateral reconstructions
- Ages 25 - 65
- All breast cancer stages and types
Who cannot join
- BMI > 35
- Active smokers
- Diabetics
- History of radiation or planned radiation
- Immunocompromised patients
Trial locations and contacts
1 site in 1 country.
United States1 site
National Center for Plastic Surgery
McLean, Virginia, 22102
About this study
Official title: Evaluating Sterile Human Acellular Dermal Matrix in Immediate Expander-Based Breast Reconstruction: A Multi-centered Prospective Cohort Study
The study is a prospective multi-centered cohort study designed to determine the safety and efficacy of AlloMax in immediate expander-based breast reconstruction. Specifically, the study is designed to determine if sterility of human acellular dermal matrix results in a lower incidence of infection and seroma. The study will determine if gamma radiation, as a method of terminally sterilizing human acellular dermal matrix, has a negative impact on graft incorporation into the host tissue.
- Medical subject headings
- Breast Neoplasms
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 |
|---|---|---|
| Allomax | The cohort consists of immediate breast reconstruction patients who have AlloMax placed at the time of their tissue expander based immediate breast reconstruction. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2011 (estimated)
- Study startJan 2010
- Primary completionFeb 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant Neoplasm of the BreastStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Center for Plastic Surgery, Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Inova Health Care Services, Ohio State University Comprehensive Cancer Center, Walter Reed Army Medical Center, C. R. Bard
- Responsible party
- Principal investigator, Mark L. Venturi, MD FACS, National Center for Plastic Surgery, Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01372917
- Sponsor's protocol ID
- 11.064
- Status last verified
- Jun 2012
- First submitted
- 13 Jun 2011
- Last updated
- 13 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Venturi ML, Mesbahi AN, Boehmler JH 4th, Marrogi AJ. Evaluating sterile human acellular dermal matrix in immediate expander-based breast reconstruction: a multicenter, prospective, cohort study. Plast Reconstr Surg. 2013 Jan;131(1):9e-18e. doi: 10.1097/PRS.0b013e3182729d4f.
PubMed 22990174
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Sterile Human Acellular Dermal Matrix in Immediate Expander-Based Breast Reconstruction: A Multi-centered Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT01372917
- Acronym / sponsor ID
- 11.064
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- National Center for Plastic Surgery, VirginiaUniversity, hospital or other
- Collaborators
- Inova Health Care Services, Ohio State University Comprehensive Cancer Center, Walter Reed Army Medical Center, C. R. Bard
- Study start
- Jan 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 14 Jun 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.
The study is a prospective multi-centered cohort study designed to determine the safety and efficacy of AlloMax in immediate expander-based breast reconstruction. Specifically, the study is designed to determine if sterility of human acellular dermal matrix results in a lower incidence of infection and seroma. The study will determine if gamma radiation, as a method of terminally sterilizing human acellular dermal matrix, has a negative impact on graft incorporation into the host tissue.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allomax | – | –The cohort consists of immediate breast reconstruction patients who have AlloMax placed at the time of their tissue expander based immediate breast reconstruction. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients who opt for immediate breast reconstruction with tissue expanders from clinic.
Key inclusion criteria (4 listed)
- Patients having immediate breast reconstruction with tissue expanders
- Unilateral or bilateral reconstructions
- Ages 25 - 65
- All breast cancer stages and types
Key exclusion criteria (5 listed)
- BMI > 35
- Active smokers
- Diabetics
- History of radiation or planned radiation
- Immunocompromised patients
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 13 Jun 2012.
- Derived from this study: PubMed 22990174Venturi ML, Mesbahi AN, Boehmler JH 4th, Marrogi AJ. Evaluating sterile human acellular dermal matrix in immediate expander-based breast reconstruction: a multicenter, prospective, cohort study. Plast Reconstr Surg. 2013 Jan;131(1):9e-18e. doi: 10.1097/PRS.0b013e3182729d4f.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Neoplasm of the Breast and Acquired Absence of the Breast, run by National Center for Plastic Surgery, Virginia 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 4 inclusion and 5 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 13 Jun 2012. 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?
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?
On the ClinicalTrials.gov record for NCT01372917, which also lists 1 linked publication.
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 13 Jun 2012.