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The Safety Evaluation of Silver Alginate (Algidex™) Dressing in Very Low Birth Weight (VLBW) Infants

NCT00593684 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-06-14

Study results available
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Summary

The purpose of this study is to test the safety of silver alginate (Algidex™) dressing in VLBW infants in preparation for a large efficacy trial.

Conditions

  • Prematurity
  • Very Low Birth Weight

Interventions

DEVICE

Silver Alginate

This is a sterile patch of polyurethane foam coated with silver alginate and maltodextrin matrix that is impregnated with 141 mg of ionic silver per 100 cm2.

Sponsors & Collaborators

  • DeRoyal Industries, Inc.

    collaborator INDUSTRY

  • Baylor Research Institute

    lead OTHER

Principal Investigators

  • Furgan Moin, M.D. · Baylor Health Care System

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
72 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2007-12-31
Completion
2007-12-31

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 NCT00593684 on ClinicalTrials.gov