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Clinical Trials/NCT01372917
NCT01372917
Completed
N/A

Evaluating Sterile Human Acellular Dermal Matrix in Immediate Expander-Based Breast Reconstruction: A Multi-centered Prospective Cohort Study

National Center for Plastic Surgery, Virginia1 site in 1 country39 target enrollmentJanuary 2010
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ConditionsMalignant Neoplasm of the BreastAcquired Absence of the Breast

Overview

Phase
N/A
Intervention
Not specified
Conditions
Malignant Neoplasm of the Breast
Sponsor
National Center for Plastic Surgery, Virginia
Enrollment
39
Locations
1
Status
Completed
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The study is a prospective multi-centered cohort study designed to determine the safety and efficacy of AlloMax in immediate expander-based breast reconstruction. Specifically, the study is designed to determine if sterility of human acellular dermal matrix results in a lower incidence of infection and seroma. The study will determine if gamma radiation, as a method of terminally sterilizing human acellular dermal matrix, has a negative impact on graft incorporation into the host tissue.

Registry
clinicaltrials.gov
Start Date
January 2010
End Date
August 2011
Last Updated
13 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
National Center for Plastic Surgery, Virginia
Responsible Party
Principal Investigator
Principal Investigator

Mark L. Venturi, MD FACS

Physician

National Center for Plastic Surgery, Virginia

Eligibility Criteria

Inclusion Criteria

  • •Patients having immediate breast reconstruction with tissue expanders
  • •Unilateral or bilateral reconstructions
  • •Ages 25 - 65
  • •All breast cancer stages and types

Exclusion Criteria

  • •BMI \> 35
  • •Active smokers
  • •Diabetics
  • •History of radiation or planned radiation
  • •Immunocompromised patients

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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