The Safety Evaluation of Silver Alginate (Algidex™) Dressing in Very Low Birth Weight (VLBW) Infants
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
- The primary outcome of this study is to assess the safety of silver alginate(Algidex™) dressing in VLBW infants [ Designated as safety issue: Yes ]
- The secondary outcome of this study is to determine the effect of silver alginate dressing use on central line infection rates. [ Designated as safety issue: No ]
|Study Start Date:||November 2005|
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.
|United States, Texas|
|Baylor University Medical Center - Women and Children's Services|
|Dallas, Texas, United States, 75204|
|Principal Investigator:||Asif Khattak, M.D.||Baylor Health Care System|