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The BREASTrial: Breast Reconstruction Evaluation Using Acellular Dermal Matrix as a Sling Trial


Phase 4
18 Years
80 Years
Open (Enrolling)
Female
Breast Cancer, Reconstructive Surgery

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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 InstituteSalt Lake City, Utah  84112