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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00964093
Recruitment Status : Unknown
Verified March 2015 by Baylor Research Institute.
Recruitment status was:  Enrolling by invitation
First Posted : August 24, 2009
Last Update Posted : March 17, 2015
DeRoyal Industries, Inc.
Information provided by (Responsible Party):
Baylor Research Institute

Brief Summary:
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 or disease Intervention/treatment Phase
Central Line Bloodstream Infections Device: Silver Alginate Not Applicable

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, 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : March 2009
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: No intervention Device: Silver Alginate
(Algidex ™)

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   up to 3 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00964093

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, Inc.
Principal Investigator: Asif Khattak, MD Baylor Health Care System
Principal Investigator: David M Kanter, MD St. Mary's Medical Center, West Palm Beach, FL

Responsible Party: Baylor Research Institute Identifier: NCT00964093     History of Changes
Other Study ID Numbers: Baylor IRB # 008-299
First Posted: August 24, 2009    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: March 2015

Keywords provided by Baylor Research Institute:
central line
very low birth weight
silver alginate

Additional relevant MeSH terms:
Communicable Diseases
Birth Weight
Body Weight
Signs and Symptoms
Alginic acid
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs