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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
50
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.
Baylor University Medical Center - Women and Children's Services
Dallas, Texas, United States
Serum Silver Concentration at 1 Day
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.
Time frame: 1 Day (first 24 hours from enrollment)
Serum Silver Concentration at 7 Days
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.
Time frame: 7 Days from enrollment
Serum Silver Concentrate at 28 Days
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.
Time frame: 28 Days from enrollment
Infection Rate
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.
Time frame: infection per 1,000 Line Days
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