The BREASTrial: Breast Reconstruction Evaluation Using Acellular Dermal Matrix as a Sling Trial
Phase 4
18 Years
80 Years
18 Years
80 Years
Open (Enrolling)
Female
Breast Cancer, Reconstructive Surgery
Female
Breast Cancer, Reconstructive Surgery
Trial Information
The BREASTrial: Breast Reconstruction Evaluation Using Acellular Dermal Matrix as a Sling Trial
Inclusion Criteria:
- Plan for immediate temporary breast reconstruction with tissue expander placement and
acellular dermal matrix in patients undergoing mastectomy
- Female gender
- Age between 18 and 80
- Consent to participate in the study
Exclusion Criteria:
- Patients not undergoing breast reconstruction following mastectomy
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Outcome Measure:
Effects of radiation on acellular dermal matrix
Outcome Time Frame:
four years
Safety Issue:
Yes
Principal Investigator
Jayant Agarwal, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Utah Hospital
Authority:
United States: Institutional Review Board
Study ID:
26658
NCT ID:
NCT00872859
Start Date:
October 2008
Completion Date:
October 2013
Related Keywords:
- Breast Cancer
- Reconstructive Surgery
- Breast Cancer
- Cancer of Breast
- Reconstructive Surgery
- Breast Neoplasms
Name | Location |
|---|---|
| University of Utah Hospital/ Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
