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

Baylor Scott and White Health (BSWH)

Status: Completed

Conditions: Very Low Birth Weight; Prematurity

Treatments: Device: Silver Alginate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00593684

0000

005-206

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 patients

Sex: All

Ages: Under 72 hours old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Algidex patch

Experimental group

Description:

Infants in this group received the Algidex patch on top of the line insertion sites of any of the following lines: umbilical arterial line, umbilical venous line, peripheral arterial line, peripheral long line, and central venous line. 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. Every 7 days, each insertion site was cleansed and then a new patch was placed and covered with a fresh occlusive dressing (Tegaderm, Opsite).

Treatment:

Device: Silver Alginate

Control group

No Intervention group

Description:

Infants in this group served as the control group and received line-dressing changes every 7 days according to standard hospital protocol specific for the type of line inserted. Insertion sites were covered with only an occlusive dressing (Tegaderm, Opsite).