The BREASTrial:Breast Reconstruction Evaluation Using Acellular Dermal Matrix as a Sling Trial
NCT ID: NCT00872859
Last Updated: 2017-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
128 participants
INTERVENTIONAL
2008-10-31
2015-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
1\. Alloderm and Dermamatrix have comparable complication rates when used for staged breast reconstruction
Secondary hypotheses:
1. The complication rates following staged breast reconstruction using Alloderm or Dermamatrix are higher if the patient requires radiation compared to those who do not require radiation.
2. Dermal matrix incorporation is not altered in patients requiring radiation compared to those who do not require radiation.
3. Dermal matrix incorporation is no different when comparing Alloderm and Dermamatrix
Specific aims:
1. Evaluate the complication rates in women undergoing staged breast reconstruction with acellular dermal matrix with or without radiation
2. Compare the complication rates between the two types of acellular dermal matrix
3. Evaluate the histologic characteristics of the dermal matrix exposed to radiation compared to that not exposed to radiation.
4. Compare the rates of incorporation of the dermal substance into surrounding tissues of those patients undergoing radiation to those not undergoing radiation
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Compare Outcomes Between Two Acellular Dermal Matrices
NCT02891759
Acellular Dermal Matrix in Tissue Expander Breast Reconstruction: A Prospective, Randomized, Clinical Trial Comparing SurgiMend PRS and AlloDerm RTU
NCT01781299
Use of Dermal Matrix in Breast Reconstruction
NCT00692692
Acellular Dermal Matrix in Breast Reconstruction
NCT02835781
A Study of the Use of Acellular Dermal Matrix for Breast Reconstruction
NCT05316324
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Dermamatrix with radiation
Implantation of Dermal Matrix substitute
Dermal Matrix implanted in post mastectomy pts at time of mastectomy.
2
Dermamatrix without radiation
Implantation of Dermal Matrix substitute
Dermal Matrix implanted in post mastectomy pts at time of mastectomy.
3
Alloderm with radiation
Implantation of Dermal Matrix substitute
Dermal Matrix implanted in post mastectomy pts at time of mastectomy.
4
Alloderm without radiation
Implantation of Dermal Matrix substitute
Dermal Matrix implanted in post mastectomy pts at time of mastectomy.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Implantation of Dermal Matrix substitute
Dermal Matrix implanted in post mastectomy pts at time of mastectomy.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Female gender
* Age between 18 and 80
* Consent to participate in the study
Exclusion Criteria
* Patients undergoing delayed breast reconstruction following mastectomy
* Patients undergoing immediate definitive breast reconstruction after mastectomy
* Patients requiring definitive reconstruction within 3 months of immediate temporary breast reconstruction
* Medical debility precluding surgical treatment
* Prior breast or chest wall irradiation
* Pregnant patients
* Male gender
18 Years
80 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Utah
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jay Agarwal
Chief of the Division of Plastic Surgery, Associate Professor of Surgery
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jayant Agarwal, MD
Role: PRINCIPAL_INVESTIGATOR
University of Utah Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Utah Hospital/ Huntsman Cancer Institute
Salt Lake City, Utah, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
26658
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.