The Safety Evaluation of Silver Alginate (Algidex™) Dressing in Very Low Birth Weight (VLBW) Infants
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | April 2006 |
| End Date: | December 2007 |
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.
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.
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.
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:
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