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

Phase 4

Completed

• Conditions: Reconstructive Surgery; Breast Cancer
• Interventions: Procedure: Implantation of Dermal Matrix substitute

• Registration Number: NCT00872859
• Lead Sponsor: University of Utah

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-03-30
• Study First Submitted QC: 2009-03-30
• Study First Posted: 2009-03-31
• Primary Completion: 2011-05
• Study Completion: 2015-02
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-16
• Last Update Posted: 2017-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4	Implantation of Dermal Matrix substitute	Alloderm without radiation
1	Implantation of Dermal Matrix substitute	Dermamatrix with radiation
2	Implantation of Dermal Matrix substitute	Dermamatrix without radiation
3	Implantation of Dermal Matrix substitute	Alloderm with radiation

Primary Outcome Measures

Name	Time	Method
Effects of radiation on acellular dermal matrix	four years

Trial Locations

Locations (1)

University of Utah Hospital/ Huntsman Cancer Institute; 🇺🇸 Salt Lake City, Utah, United States