N/A
Completed N=50
The Safety Evaluation of Silver Alginate (Algidex™) Dressing in Very Low Birth Weight (VLBW) Infants
Source: ClinicalTrials.gov NCT00593684 ↗Enrolled (actual)
50
Serious AEs
12.0%
Results posted
Apr 2015
Primary outcomePrimary: Serum Silver Concentration at 1 Day — 7.6; 0.22 ng ml -1
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Silver Concentration at 1 Day |
7.6; 0.22 | — |
| PRIMARY Serum Silver Concentration at 7 Days |
4.79; 0.23 | — |
| PRIMARY Serum Silver Concentrate at 28 Days |
3.19; 0.21 | — |
| SECONDARY Infection Rate |
6.69; 12.34 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00593684). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.