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

NCT00872859 | Completed Phase 4 DMC

• 1 other identifier: 26658
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Hypothesis: 1\. Alloderm and Dermamatrix have comparable complication rates when used for staged breast reconstruction Secondary hypotheses:

1. 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. 2.Dermal matrix incorporation is not altered in patients requiring radiation compared to those who do not require radiation.
3. 3.Dermal matrix incorporation is no different when comparing Alloderm and Dermamatrix
4. 4.Evaluate the complication rates in women undergoing staged breast reconstruction with acellular dermal matrix with or without radiation
5. 5.Compare the complication rates between the two types of acellular dermal matrix
6. 6.Evaluate the histologic characteristics of the dermal matrix exposed to radiation compared to that not exposed to radiation.
7. 7.Compare the rates of incorporation of the dermal substance into surrounding tissues of those patients undergoing radiation to those not undergoing radiation

Conditions

Breast Cancer; Reconstructive Surgery

Keywords

Breast Cancer; Cancer of Breast; Reconstructive Surgery

Outcome Measures

Primary Outcomes (1)

• Effects of radiation on acellular dermal matrix

  four years

Study Arms (4)

1

EXPERIMENTAL

Dermamatrix with radiation

Procedure: Implantation of Dermal Matrix substitute

2

EXPERIMENTAL

Dermamatrix without radiation

Procedure: Implantation of Dermal Matrix substitute

3

EXPERIMENTAL

Alloderm with radiation

Procedure: Implantation of Dermal Matrix substitute

4

EXPERIMENTAL

Alloderm without radiation

Procedure: Implantation of Dermal Matrix substitute

Interventions

Implantation of Dermal Matrix substitute PROCEDURE

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

Also known as: Dermamatrix, Alloderm, Dermal Matrix

1; 2; 3; 4

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Hospital/ Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Alloderm

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jayant Agarwal, MD

  University of Utah Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the Division of Plastic Surgery, Associate Professor of Surgery

Study Record Dates

• First Submitted: March 30, 2009
• First Posted: March 31, 2009
• Study Start: October 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: February 1, 2015
• Last Updated: May 18, 2017

Record last verified: 2017-05

Locations

US (1)