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Safety and Immunogenicity Study of Recombinant Thrombin (rThrombin) in Pediatric Participants

NCT00859547 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2012-01-26

Study results available
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Summary

The objective of this study is to assess the safety and immunogenicity of recombinant thrombin (rThrombin) administered as an aid to hemostasis during burn wound excision and skin grafting in pediatric patients, newborn through 17 years of age.

Conditions

  • Blood Loss, Surgical

Interventions

BIOLOGICAL

rThrombin, 1000 IU/mL

rThrombin,1000 IU/mL, 1000 IU/mL, applied topically to the bleeding site during a single surgery procedure on Day 1.

Sponsors & Collaborators

  • ZymoGenetics

    lead INDUSTRY

Principal Investigators

  • Kevin Foster, MD · Arizona Burn Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-01-31
Completion
2010-01-31

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 NCT00859547 on ClinicalTrials.gov