N/A N=50 Randomized Prevention

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

Prematurity · Very Low Birth Weight

Bottom Line

View on ClinicalTrials.gov: NCT00593684 ↗

Enrolled (actual)

Serious AEs

12.0%

Results posted

Apr 2015

Primary outcome: Primary: Serum Silver Concentration at 1 Day — 7.6; 0.22 ng ml -1

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Silver Alginate (Device)
Age: Pediatric
Sex: All
Sponsor: Baylor Research Institute
Primary completion: Dec 2007

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	—

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.

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

View full record on ClinicalTrials.gov →

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.