The Effectiveness of Silver Alginate (Algidex) Patch in the Prevention of Central Line Infections in Very Low Birth Weight Infants

Central Line Bloodstream Infections Clinical Trial

Official title:

The Efficacy of Silver Alginate (Algidex®) Dressing in Reducing Central Line Infections in Very Low Birth Weight (VLBW) Infants: A Multicenter Collaborative Randomized Controlled Trial.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00964093
• Other study ID #: Baylor IRB # 008-299
• Status: Enrolling by invitation
• Phase: N/A
• First received: August 21, 2009
• Last updated: March 12, 2015
• Start date: March 2009
• Est. completion date: December 2015

Study information

• Verified date: March 2015
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether silver alginate (Algidex) patch is effective in the prevention of central line infections in very low birth weight infants.

Description:

With rapid technological advancement, the increased use of vascular catheters has not only improved patient care strategies, but also contributed to the risk of infection. Unfortunately, catheter related blood stream infections still remain one of the major causes of morbidity in VLBW infants. In the United States, approximately 850,000 infections are attributed to catheters annually, occurring primarily in intensive care unit patients. The National Institute of Child Health and Human Development stated that 20% of infants less than 1500 grams will have at least one positive blood culture delaying their stay in the neonatal intensive care unit (NICU).

One approach to reducing the incidence of infection could be utilizing the antimicrobial properties of silver. Silver alginate has been proven safe and beneficial in the adult population in preventing catheter related infections. Studies done in mice and rats suggest acute toxicity occurring when the animals were given 23 mg of silver acetate/kg of body weight and chronic toxicity noticed when animals were given 1.5 mg/kg/day (5) Chronic toxicity in humans was shown with ingestion of 13 mg/kg/day (3) In our recently concluded pilot randomized controlled trial done in VLBW infants, safety of silver alginate was demonstrated by lack of skin reactions to the patches and mild increase in serum silver level ( Khattak et al; Pediatrics research March 2008, clinicaltrials.gov id: NCT00593684 ). However, there is no clinical evidence of efficacy in VLBW neonatal population. Based on the data from our pilot safety study, we hypothesize that using silver alginate dressing in this population will be efficacious in the prevention of blood stream infections. Although initial studies suggest that absorbed silver is not in a range toxic to human infants, we will continue to monitor silver levels in certain infants.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 3 Weeks

Eligibility

Inclusion Criteria:

1. Infants with birth weights between 500 and 1500 grams admitted to the NICU with any of the following lines will be eligible for inclusion in this study

1. umbilical arterial line (UAL)

2. umbilical venous line (UVL)

3. peripheral arterial line (PAL)

4. peripheral long line (PLL)

5. central venous line (CVL)

2. Each eligible subject will be randomized to receive either standard of care or silver alginate dressing. Dressings will be changed every 7 days in accordance to current facility protocols.

Exclusion Criteria:

1. Any infant born with a lethal abnormality or who has received topical Silver therapy will be excluded from the study.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Birth Weight
• Central Line Bloodstream Infections
• Communicable Diseases
• Infection

Intervention

Device:
• Silver Alginate
(Algidex ™)

Locations

Country	Name	City	State
United States	Baylor University Medical Center - Women and Children's Services	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor Research Institute	DeRoyal Industries, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective of this trial is to assess the efficacy of silver alginate dressing in reducing central line infections in VLBW infants		2 years	No
Secondary	The secondary objectives are to compare mortality and total days of hospitalization between the groups. Safety will be assessed by obtaining silver levels, skin integrity, and adverse events related to the dressing.		2 years	Yes