Overview

This trial is active, not recruiting.

Conditions breast cancer, reconstructive surgery
Treatment implantation of dermal matrix substitute
Phase phase 4
Sponsor University of Utah
Start date October 2008
End date May 2011
Trial size 196 participants
Trial identifier NCT00872859, 26658

Summary

Primary Hypothesis:

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(Experimental)
Dermamatrix with radiation
implantation of dermal matrix substitute Dermamatrix
Dermal Matrix implanted in post mastectomy pts at time of mastectomy.
(Experimental)
Dermamatrix without radiation
implantation of dermal matrix substitute Dermamatrix
Dermal Matrix implanted in post mastectomy pts at time of mastectomy.
(Experimental)
Alloderm with radiation
implantation of dermal matrix substitute Dermamatrix
Dermal Matrix implanted in post mastectomy pts at time of mastectomy.
(Experimental)
Alloderm without radiation
implantation of dermal matrix substitute Dermamatrix
Dermal Matrix implanted in post mastectomy pts at time of mastectomy.

Primary Outcomes

Measure
Effects of radiation on acellular dermal matrix
time frame: four years

Eligibility Criteria

Female participants from 18 years up to 80 years old.

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

Additional Information

Official title The BREASTrial: Breast Reconstruction Evaluation Using Acellular Dermal Matrix as a Sling Trial
Principal investigator Jayant Agarwal, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2012.
Information provided to ClinicalTrials.gov by University of Utah.