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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00872859
• Other study ID #: 26658
• Status: Completed
• Phase: Phase 4
• First received: March 30, 2009
• Last updated: May 16, 2017
• Start date: October 2008
• Est. completion date: February 2015

Study information

• Verified date: May 2017
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: February 2015
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Reconstructive Surgery

Intervention

Procedure:
• Implantation of Dermal Matrix substitute
Dermal Matrix implanted in post mastectomy pts at time of mastectomy.

Locations

Country	Name	City	State
United States	University of Utah Hospital/ Huntsman Cancer Institute	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of radiation on acellular dermal matrix		four years