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

NCT00593684 | Completed Results

• 2 other identifiers: 005-2060000
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prematurity; Very Low Birth Weight

Keywords

neonate; central lines; very low birth weight; silver alginate

Outcome Measures

Primary Outcomes (3)

• Serum Silver Concentration at 1 Day

  Serum silver concentrations were obtained from both groups on study days 1, 7, and 28. Study day 1 was defined as the 24 hour period in which participants enrolled in the study. Here we are examining the results of first day, or 24 hours from enrollment. Silver samples were analyzed using a dual inductively coupled plasma -mass spectrometry methodology. Accepted reference values for non-exposure silver concentrations are defined as \<15 ng ml -1 with standard Mayo Clinic reference technique.

  1 Day (first 24 hours from enrollment)

• Serum Silver Concentration at 7 Days

  Serum silver concentrations were obtained from both groups on study days 1, 7, and 28. Study day 1 was defined as the 24 hour period in which participants enrolled in the study. Here we examine the results at 7 days from enrollment. Silver samples were analyzed using a dual inductively coupled plasma -mass spectrometry methodology. Accepted reference values for non-exposure silver concentrations are defined as \<15 ng ml -1 with standard Mayo Clinic reference technique.

  7 Days from enrollment

• Serum Silver Concentrate at 28 Days

  Serum silver concentrations were obtained from both groups on study days 1, 7, and 28. Study day 1 was defined as the 24 hour period in which participants enrolled in the study. Here we examine results at 28 days from enrollment. Silver samples were analyzed using a dual inductively coupled plasma -mass spectrometry methodology. Accepted reference values for non-exposure silver concentrations are defined as \<15 ng ml -1 with standard Mayo Clinic reference technique.

  28 Days from enrollment

Secondary Outcomes (1)

• Infection Rate

  infection per 1,000 Line Days

Study Arms (2)

Algidex patch

EXPERIMENTAL

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).

Device: Silver Alginate

Control group

NO INTERVENTION

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).

Interventions

Silver Alginate 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.

Also known as: Algidex™ extra small patches

Algidex patch

Eligibility Criteria

• Age: Up to 72 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• N/A

Sponsors & Collaborators

• Baylor Research Institute: lead
• DeRoyal Industries, Inc.: collaborator

Study Sites (1)

Baylor University Medical Center - Women and Children's Services

Dallas, Texas, 75204, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Results Point of Contact

• Title: Furgan Moin, MD
• Organization: Baylor Health Care System

Furgan.Moin@baylorhealth.edu

214-820-7604

Study Officials

• Furgan Moin, M.D.

  Baylor Health Care System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2008
• First Posted: January 15, 2008
• Study Start: April 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: June 14, 2017
• Results First Posted: April 7, 2015

Record last verified: 2017-06

Locations

US (1)