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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2007-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Prematurity Very Low Birth Weight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Algidex patch

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).

Group Type EXPERIMENTAL

Silver Alginate

Intervention Type DEVICE

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.

Control group

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Silver Alginate

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.

Intervention Type DEVICE

Other Intervention Names

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Algidex™ extra small patches

Eligibility Criteria

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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).