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The Effectiveness of Silver Alginate (Algidex) Patch in the Prevention of Central Line Infections in Very Low Birth Weight Infants

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
DeRoyal Industries
Information provided by (Responsible Party):
Baylor Research Institute
ClinicalTrials.gov Identifier:
NCT00964093
First received: August 21, 2009
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to determine whether silver alginate (Algidex) patch is effective in the prevention of central line infections in very low birth weight infants.


Condition Intervention
Central Line Bloodstream Infections
Device: Silver Alginate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Efficacy of Silver Alginate (Algidex®) Dressing in Reducing Central Line Infections in Very Low Birth Weight (VLBW) Infants: A Multicenter Collaborative Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Baylor Research Institute:

Primary Outcome Measures:
  • The primary objective of this trial is to assess the efficacy of silver alginate dressing in reducing central line infections in VLBW infants [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary objectives are to compare mortality and total days of hospitalization between the groups. Safety will be assessed by obtaining silver levels, skin integrity, and adverse events related to the dressing. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: March 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No intervention Device: Silver Alginate
(Algidex ™)

Detailed Description:

With rapid technological advancement, the increased use of vascular catheters has not only improved patient care strategies, but also contributed to the risk of infection. Unfortunately, catheter related blood stream infections still remain one of the major causes of morbidity in VLBW infants. In the United States, approximately 850,000 infections are attributed to catheters annually, occurring primarily in intensive care unit patients. The National Institute of Child Health and Human Development stated that 20% of infants less than 1500 grams will have at least one positive blood culture delaying their stay in the neonatal intensive care unit (NICU).

One approach to reducing the incidence of infection could be utilizing the antimicrobial properties of silver. Silver alginate has been proven safe and beneficial in the adult population in preventing catheter related infections. Studies done in mice and rats suggest acute toxicity occurring when the animals were given 23 mg of silver acetate/kg of body weight and chronic toxicity noticed when animals were given 1.5 mg/kg/day (5) Chronic toxicity in humans was shown with ingestion of 13 mg/kg/day (3) In our recently concluded pilot randomized controlled trial done in VLBW infants, safety of silver alginate was demonstrated by lack of skin reactions to the patches and mild increase in serum silver level ( Khattak et al; Pediatrics research March 2008, clinicaltrials.gov id: NCT00593684 ). However, there is no clinical evidence of efficacy in VLBW neonatal population. Based on the data from our pilot safety study, we hypothesize that using silver alginate dressing in this population will be efficacious in the prevention of blood stream infections. Although initial studies suggest that absorbed silver is not in a range toxic to human infants, we will continue to monitor silver levels in certain infants.

  Eligibility

Ages Eligible for Study:   up to 3 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Infants with birth weights between 500 and 1500 grams admitted to the NICU with any of the following lines will be eligible for inclusion in this study

    1. umbilical arterial line (UAL)
    2. umbilical venous line (UVL)
    3. peripheral arterial line (PAL)
    4. peripheral long line (PLL)
    5. central venous line (CVL)
  2. Each eligible subject will be randomized to receive either standard of care or silver alginate dressing. Dressings will be changed every 7 days in accordance to current facility protocols.

Exclusion Criteria:

1. Any infant born with a lethal abnormality or who has received topical Silver therapy will be excluded from the study.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00964093

Locations
United States, Texas
Baylor University Medical Center - Women and Children's Services
Dallas, Texas, United States, 75204
Sponsors and Collaborators
Baylor Research Institute
DeRoyal Industries
Investigators
Principal Investigator: Asif Khattak, MD Baylor Health Care System
Principal Investigator: David M Kanter, MD St. Mary's Medical Center, West Palm Beach, FL
  More Information

No publications provided

Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT00964093     History of Changes
Other Study ID Numbers: Baylor IRB # 008-299
Study First Received: August 21, 2009
Last Updated: March 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor Research Institute:
premature
infection
central line
very low birth weight
silver alginate
Algidex
neonatal
NICU

Additional relevant MeSH terms:
Birth Weight
Communicable Diseases
Infection
Body Weight
Signs and Symptoms
Alginic acid
Coagulants
Hematologic Agents
Hemostatics
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Radiation-Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014