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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by:

University of Utah

ClinicalTrials.gov Identifier:

NCT00872859

First received: March 30, 2009

Last updated: June 1, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

March 30, 2009

Last Updated Date

June 1, 2012

Start Date ^ICMJE

October 2008

Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Effects of radiation on acellular dermal matrix [ Time Frame: four years ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00872859 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

Primary Hypothesis:

1. Alloderm and Dermamatrix have comparable complication rates when used for staged breast reconstruction

Secondary hypotheses:

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.
Dermal matrix incorporation is not altered in patients requiring radiation compared to those who do not require radiation.
Dermal matrix incorporation is no different when comparing Alloderm and Dermamatrix

Specific aims:

Evaluate the complication rates in women undergoing staged breast reconstruction with acellular dermal matrix with or without radiation
Compare the complication rates between the two types of acellular dermal matrix
Evaluate the histologic characteristics of the dermal matrix exposed to radiation compared to that not exposed to radiation.
Compare the rates of incorporation of the dermal substance into surrounding tissues of those patients undergoing radiation to those not undergoing radiation

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Breast Cancer
Reconstructive Surgery

Intervention ^ICMJE

Procedure: Implantation of Dermal Matrix substitute

Dermal Matrix implanted in post mastectomy pts at time of mastectomy.

Other Names:

Dermamatrix
Alloderm
Dermal Matrix

Study Arm (s)

Experimental: 1
Dermamatrix with radiation

Intervention: Procedure: Implantation of Dermal Matrix substitute
Experimental: 2
Dermamatrix without radiation

Intervention: Procedure: Implantation of Dermal Matrix substitute
Experimental: 3
Alloderm with radiation

Intervention: Procedure: Implantation of Dermal Matrix substitute
Experimental: 4
Alloderm without radiation

Intervention: Procedure: Implantation of Dermal Matrix substitute

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

196

Estimated Completion Date

October 2013

Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00872859

Other Study ID Numbers ^ICMJE

26658

Has Data Monitoring Committee

Yes

Responsible Party

Jayant Agarwal MD, University of Utah/Huntsman Cancer Institute

Study Sponsor ^ICMJE

University of Utah

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jayant Agarwal, MD

University of Utah Hospital

Information Provided By

University of Utah

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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