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Evaluating AlloMax in Immediate Expander-Based Breast Reconstruction Study

NCT01372917 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 39

Last updated 2012-06-13

No results posted yet for this study

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.

Conditions

  • Malignant Neoplasm of the Breast
  • Acquired Absence of the Breast

Sponsors & Collaborators

  • Inova Health Care Services

    collaborator OTHER

  • Ohio State University Comprehensive Cancer Center

    collaborator OTHER

  • Walter Reed Army Medical Center

    collaborator FED

  • C. R. Bard

    collaborator INDUSTRY

  • National Center for Plastic Surgery, Virginia

    lead OTHER

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2011-02-28
Completion
2011-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01372917 on ClinicalTrials.gov