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

This study has been completed.
Sponsor:
Collaborator:
DeRoyal
Information provided by (Responsible Party):
Baylor Research Institute
ClinicalTrials.gov Identifier:
NCT00593684
First received: January 4, 2008
Last updated: March 24, 2015
Last verified: March 2015
  Purpose

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.


Condition Intervention
Prematurity
Very Low Birth Weight
Device: Silver Alginate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Baylor Research Institute:

Primary Outcome Measures:
  • Serum Silver Concentration at 1 Day [ Time Frame: 1 Day (first 24 hours from enrollment) ] [ Designated as safety issue: Yes ]
    Serum silver concentrations were obtained from both groups on study days 1, 7, and 28. Study day 1 was defined as the 24 hour period in which participants enrolled in the study. Here we are examining the results of first day, or 24 hours from enrollment. Silver samples were analyzed using a dual inductively coupled plasma -mass spectrometry methodology. Accepted reference values for non-exposure silver concentrations are defined as <15 ng ml -1 with standard Mayo Clinic reference technique.

  • Serum Silver Concentration at 7 Days [ Time Frame: 7 Days from enrollment ] [ Designated as safety issue: Yes ]
    Serum silver concentrations were obtained from both groups on study days 1, 7, and 28. Study day 1 was defined as the 24 hour period in which participants enrolled in the study. Here we examine the results at 7 days from enrollment. Silver samples were analyzed using a dual inductively coupled plasma -mass spectrometry methodology. Accepted reference values for non-exposure silver concentrations are defined as <15 ng ml -1 with standard Mayo Clinic reference technique.

  • Serum Silver Concentrate at 28 Days [ Time Frame: 28 Days from enrollment ] [ Designated as safety issue: Yes ]
    Serum silver concentrations were obtained from both groups on study days 1, 7, and 28. Study day 1 was defined as the 24 hour period in which participants enrolled in the study. Here we examine results at 28 days from enrollment. Silver samples were analyzed using a dual inductively coupled plasma -mass spectrometry methodology. Accepted reference values for non-exposure silver concentrations are defined as <15 ng ml -1 with standard Mayo Clinic reference technique.


Secondary Outcome Measures:
  • Infection Rate [ Time Frame: infection per 1,000 Line Days ] [ Designated as safety issue: No ]
    Infection was defined as recovery of a bacterial pathogen or fungus from any single blood culture. Infection rate was defined as Infections/1000 line days.


Enrollment: 50
Study Start Date: April 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Algidex patch
Infants in this group received the Algidex patch on top of the line insertion sites of any of the following lines: umbilical arterial line, umbilical venous line, peripheral arterial line, peripheral long line, and central venous line. 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. Every 7 days, each insertion site was cleansed and then a new patch was placed and covered with a fresh occlusive dressing (Tegaderm, Opsite).
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.
Other Name: Algidex™ extra small patches
No Intervention: Control group
Infants in this group served as the control group and received line-dressing changes every 7 days according to standard hospital protocol specific for the type of line inserted. Insertion sites were covered with only an occlusive dressing (Tegaderm, Opsite).

Detailed Description:

We are conducting a pilot randomized controlled trial in VLBW infants to evaluate the safety of silver alginate (Algidex™) dressing compared to standard catheter care. Following parental consent, infants are randomized to receive silver alginate or standard of care dressing. Infants with birth weights less than 1,500 grams admitted to Baylor University Medical Center (BUMC) NICU with any of the following lines are eligible for inclusion into this study up to 72 hours after birth: umbilical arterial line (UAL), umbilical venous line (UVL), peripheral arterial line (PAL), peripheral long line (PLL), and central venous line (CVL). Safety is assessed by measuring silver levels and monitoring for cutaneous reactions. Dressings are changed every seven days. Silver levels are drawn on study days 1, 7, and 28. Blood culture results are used to compare infection rates between the two groups. Patient demographics and clinical conditions are recorded. Results will be analyzed based on intention to treat.

  Eligibility

Ages Eligible for Study:   up to 72 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infants with birth weights less than 1,500 grams admitted to Baylor University Medical Center (BUMC) NICU with any of the following lines are eligible for inclusion into this study up to 72 hours after birth: umbilical arterial line (UAL), umbilical venous line (UVL), peripheral arterial line (PAL), peripheral long line (PLL), and central venous line (CVL).

Exclusion Criteria:

  • N/A
  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: NCT00593684

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
Investigators
Principal Investigator: Furgan Moin, M.D. Baylor Health Care System
  More Information

No publications provided

Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT00593684     History of Changes
Other Study ID Numbers: Baylor IRB #005-206, 0000
Study First Received: January 4, 2008
Results First Received: February 16, 2012
Last Updated: March 24, 2015
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Birth Weight
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 May 21, 2015