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| ID | Type | Description | Link |
|---|---|---|---|
| WUSM HRPO# 05-1186 |
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We proposed to perform a prospective randomized controlled trial to study the effect of the use of a commercially-available chlorhexidine-impregnated sponge (Biopatch) as part of central venous catheter care on catheter-related bloodstream infections among patients in two Barnes-Jewish Hospital ICUs.
At the time of the inception of this study, there were no published randomized controlled trial on the efficacy of the Biopatch in reducing bloodstream infections. Preliminary data has shown that the Biopatch decreases colonization of the catheter exit site and thereby decrease bloodstream infections but this was at that time only theoretical.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | No Intervention | Patients in this arm will continue to get routine care | |
| Chlorhexidine-impregnated foam dressing | Experimental | Patient's catheters were cleaned with chlorhexidine-alcohol solution at least weekly before application of the Biopatch. These were evaluated daily and if the dressing was bloody, soiled or damaged, the dressing and the Biopatch were replaced prior to the 7-day period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhexidine-impregnated foam dressing | Device | Patients in the treatment arm will have the Biopatch incorporated into their catheter care protocol. ICU nurses were instructed on the proper use of this novel dressing/sponge. Catheter dressing changes will only be done every 7 days unless there is visible blood, soiling underneath the dressing, or if the dressing comes off. |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Catheter Related Bloodstream Infections (BSI) /1000 Catheter Days in Both Arms | The outcome measure is the number of episodes of bloodstream infections (BSI) divided by the catheter days at risk multiplied by 1000 for standardization | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Sepsis Episodes/Per 1000 Catheter Days | This measure is a combination of patients with positive blood cultures (BSI) and patients who had signs and symptoms of sepsis but with negative blood cultures. These patients still required treatment with antibiotics. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernard C Camins, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barnes- Jewish Hospital | St Louis | Missouri | 63110 | United States |
Patients or family member authorized to consent for the patient (if the patient was not competent to consent to the study) were approached by study personnel for inclusion into the study. Written informed consent was obtained for all subjects and randomization group was assigned in blocks of 4.
The patients were recruited from two ICUs at BJH. The nurse was asked to page the research coordinators on patients who were scheduled to have a central venous catheter placed for IV access.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care | Patients in this arm will continue to get the standard catheter care protocol without the use of the chlorhexidine-impregnated foam dressing. |
| FG001 | Chlorhexidine-impregnated Foam Dressing |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care | Patients in this arm will continue to get the standard catheter care protocol without the use of the chlorhexidine-impregnated foam dressing. |
| BG001 | Chlorhexidine-impregnated Foam Dressing |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Age at enrollment was collected for this measure |
| 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 | The Number of Catheter Related Bloodstream Infections (BSI) /1000 Catheter Days in Both Arms | The outcome measure is the number of episodes of bloodstream infections (BSI) divided by the catheter days at risk multiplied by 1000 for standardization | Based on previous data (unpublished),there would be a 60% reduction in the incidence of bloodstream infections-- the primary outcome. The number of patients included in this study had a large enough sample size to show a statistical difference. | Posted | Number | BSIs /1000 catheter days | 2 years |
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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 | Standard of Care | Patients in this arm will continue to get the standard catheter care protocol without the use of the chlorhexidine-impregnated foam dressing. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bernard C. Camins, MD | Washington University School of Medicine | 3144548351 | bcamins@dom.wustl.edu |
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Patients in this group had the Biopatch applied on the catheter exit site after insertion of the catheter. Dressings were changed every 7 days along with the Biopatch after the skin was cleaned with a chlorhexidine-alcohol antiseptic solution. Dressings were assessed daily and changed if they were soiled, non-intact, or bloody before the 7-day period was up.
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
Patients in this group had the Biopatch applied on the catheter exit site after insertion of the catheter. Dressings were changed every 7 days along with the Biopatch after the skin was cleaned with a chlorhexidine-alcohol antiseptic solution. Dressings were assessed daily and changed if they were soiled, non-intact, or bloody before the 7-day period was up.
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| Secondary | Clinical Sepsis Episodes/Per 1000 Catheter Days | This measure is a combination of patients with positive blood cultures (BSI) and patients who had signs and symptoms of sepsis but with negative blood cultures. These patients still required treatment with antibiotics. | Posted | Number | sepsis episodes/1000 catheter days | 2 years |
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| 0 |
| 534 |
| 0 |
| 534 |
| EG001 | Chlorhexidine-impregnated Foam Dressing | 0 | 554 | 0 | 554 |
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