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| ID | Type | Description | Link |
|---|---|---|---|
| 0000 |
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| Name | Class |
|---|---|
| DeRoyal Industries, Inc. | INDUSTRY |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Infection Rate | 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. | infection per 1,000 Line Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Furgan Moin, M.D. | Baylor Health Care System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor University Medical Center - Women and Children's Services | Dallas | Texas | 75204 | United States |
Enrollment and group assignment occurred concurrently.
Patients were enrolled at the Baylor University Medical Center Neonatal Intensive Care Unit between April 2006 and December 2007.
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| ID | Title | Description |
|---|---|---|
| FG000 | Algidex Patch | |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Algidex Patch | |
| BG001 | 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). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | weeks of gestation |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Study design included intent-to-treat for data collection and intention to stop if signs of toxicities or adverse effects were noted. | Posted | Mean | Standard Deviation | ng ml -1 | 1 Day (first 24 hours from enrollment) |
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Time of enrollment (signed consent) until hospital discharge.
Serum Silver concentration measures ended at day 28 and/or when central line discontinued
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Algidex Patch |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Pregnancy, puerperium and perinatal conditions | MedDRA (10.0) | Systematic Assessment | Complications of prematurity |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Furgan Moin, MD | Baylor Health Care System | 214-820-7604 | Furgan.Moin@baylorhealth.edu |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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|
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| weeks |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Birth Weight (grams) | Mean | Standard Deviation | Grams |
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| Average Line Days | umbilical arterial line, umbilical venous line, peripheral arterial line, peripheral long line, and central venous line calculated per 1,000 days. | Mean | Standard Deviation | line days |
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| OG001 | 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). |
|
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| Primary | 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. | One subject in each group died | Posted | Mean | Standard Deviation | ng ml -1 | 7 Days from enrollment |
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| Primary | 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. | two subjects died in the treatment group; one subject died in the control group | Posted | Mean | Standard Deviation | ng ml -1 | 28 Days from enrollment |
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| Secondary | Infection Rate | 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. | Posted | Number | Infection per 1,000 line days | infection per 1,000 Line Days |
|
|
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| 2 |
| 25 |
| 0 |
| 25 |
| EG001 | 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). | 4 | 25 | 0 | 25 |
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| D000091642 | Urogenital Diseases |