Trial Outcomes & Findings for The Safety Evaluation of Silver Alginate (Algidex™) Dressing in Very Low Birth Weight (VLBW) Infants (NCT NCT00593684)

NCT ID: NCT00593684

Last Updated: 2017-06-14

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: 1 Day (first 24 hours from enrollment)
• Results posted on: 2017-06-14

Participant Flow

Patients were enrolled at the Baylor University Medical Center Neonatal Intensive Care Unit between April 2006 and December 2007.

Enrollment and group assignment occurred concurrently.

Participant milestones

Measure	Algidex Patch	Control 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).
Overall Study STARTED	25	25
Overall Study COMPLETED	23	24
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Measure	Algidex Patch	Control 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).
Overall Study Death	2	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Algidex Patch n=25 Participants	Control n=25 Participants 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).	Total n=50 Participants Total of all reporting groups
Age, Continuous	27.3 weeks STANDARD_DEVIATION 2.03 • n=5 Participants	27.2 weeks STANDARD_DEVIATION 1.85 • n=7 Participants	27.25 weeks STANDARD_DEVIATION 2 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants	6 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	15 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Birth Weight (grams)	955 Grams STANDARD_DEVIATION 250 • n=5 Participants	913 Grams STANDARD_DEVIATION 209 • n=7 Participants	934 Grams STANDARD_DEVIATION 229 • n=5 Participants
Average Line Days	17.95 line days STANDARD_DEVIATION 8.8 • n=5 Participants	19 line days STANDARD_DEVIATION 9.9 • n=7 Participants	18.5 line days STANDARD_DEVIATION 9.35 • n=5 Participants

PRIMARY outcome

Timeframe: 1 Day (first 24 hours from enrollment)

Population: Study design included intent-to-treat for data collection and intention to stop if signs of toxicities or adverse effects were noted.

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.

Outcome measures

Measure	Algidex Patch n=25 Participants The group of patients that were randomized to receive the Algidex patch during the study.	Control n=24 Participants 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).
Serum Silver Concentration at 1 Day	7.6 ng ml -1 Standard Deviation 20.93	0.22 ng ml -1 Standard Deviation 0.09

PRIMARY outcome

Timeframe: 7 Days from enrollment

Population: One subject in each group died

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.

Outcome measures

Measure	Algidex Patch n=24 Participants The group of patients that were randomized to receive the Algidex patch during the study.	Control n=24 Participants 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).
Serum Silver Concentration at 7 Days	4.79 ng ml -1 Standard Deviation 4.37	0.23 ng ml -1 Standard Deviation 0.14

PRIMARY outcome

Timeframe: 28 Days from enrollment

Population: two subjects died in the treatment group; one subject died in the control group

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.

Outcome measures

Measure	Algidex Patch n=23 Participants The group of patients that were randomized to receive the Algidex patch during the study.	Control n=24 Participants 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).
Serum Silver Concentrate at 28 Days	3.19 ng ml -1 Standard Deviation 3.23	0.21 ng ml -1 Standard Deviation 0.07

SECONDARY outcome

Timeframe: infection per 1,000 Line Days

Infection was defined as recovery of a bacterial pathogen or fungus from any single blood culture. Infection rate was defined as Infections/1000 line days.

Outcome measures

Measure	Algidex Patch n=25 Participants The group of patients that were randomized to receive the Algidex patch during the study.	Control n=24 Participants 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).
Infection Rate	6.69 Infection per 1,000 line days	12.34 Infection per 1,000 line days

Adverse Events

Algidex Patch

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Algidex Patch n=25 participants at risk	Control n=25 participants at risk 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).
Pregnancy, puerperium and perinatal conditions Death	8.0% 2/25 • Time of enrollment (signed consent) until hospital discharge. Serum Silver concentration measures ended at day 28 and/or when central line discontinued	16.0% 4/25 • Time of enrollment (signed consent) until hospital discharge. Serum Silver concentration measures ended at day 28 and/or when central line discontinued

Other adverse events

Adverse event data not reported

Additional Information

Furgan Moin, MD

Baylor Health Care System

Phone: 214-820-7604

Email: Furgan.Moin@baylorhealth.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place