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Healthcare-associated infections are a major cause of morbidity among critically ill patients. Bathing critically ill patients with cloths impregnated with the broad-spectrum antimicrobial agent chlorhexidine-gluconate may decrease healthcare-associated infections. The purpose of this study is to evaluate the effect of daily bathing with disposable chlorhexidine-impregnated bathing cloths, as compared to daily bathing with disposable standard non-chlorhexidine-impregnated bathing cloths, on the rates of healthcare-associated infections in critically-ill patients.
Hypothesis: Daily bathing of the skin with chlorhexidine-impregnated bathing cloths will result in reduced rates of healthcare-associated infections in patients admitted to intensive care units (ICU).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chlorhexidine bathing | Experimental | Patients in an ICU randomized to treatment arm 1 will be bathed with single use, no rinse, disposable cloths impregnated with 2% chlorhexidine gluconate solution (Sage® 2% Chlorhexidine Gluconate Cloths). Bathing of the skin of the arms, chest, abdomen, back, both legs, perineum, and buttocks will be performed daily and as needed after patients become soiled. The face and neck will not be bathed in this manner but will be bathed with water-moistened washcloths. All other infection control and cleaning procedures will be performed per the current practice in each intensive care unit. |
|
| Non-chlorhexidine bathing | Active Comparator | Patients in an ICU randomized to treatment arm 2 will be bathed with single use, no rinse, disposable cloths that do not contain chlorhexidine gluconate solution (Sage Comfort Bath® Cleansing Washcloths). Bathing of the skin of the arms, chest, abdomen, back, both legs, perineum, and buttocks will be performed daily and as needed after patients become soiled. The face and neck will not be bathed in this manner but will be bathed with water-moistened washcloths. All other infection control and cleaning procedures will be performed per the current protocols in each intensive care unit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhexidine bathing | Other | Patients in an ICU randomized to treatment arm 1 will be bathed with single use, no rinse, disposable cloths impregnated with 2% chlorhexidine gluconate solution (Sage® 2% Chlorhexidine Gluconate Cloths). Bathing of the skin of the arms, chest, abdomen, back, both legs, perineum, and buttocks will be performed daily and as needed after patients become soiled. The face and neck will not be bathed in this manner but will be bathed with water-moistened washcloths. All other infection control and cleaning procedures will be performed per the current practice in each intensive care unit. |
| Measure | Description | Time Frame |
|---|---|---|
| A composite of healthcare-associated infections | A composite of the following healthcare-associated infections:
| Daily |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of each individual site infection included in the composite calculation above |
| Daily |
| Skin reactions |
| Measure | Description | Time Frame |
|---|---|---|
| Subgroup analysis by the individual intensive care unit | One year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael J Noto, MD, PhD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25602496 | Derived | Noto MJ, Domenico HJ, Byrne DW, Talbot T, Rice TW, Bernard GR, Wheeler AP. Chlorhexidine bathing and health care-associated infections: a randomized clinical trial. JAMA. 2015 Jan 27;313(4):369-78. doi: 10.1001/jama.2014.18400. |
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| ID | Term |
|---|---|
| D003428 | Cross Infection |
| ID | Term |
|---|---|
| D007239 | Infections |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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|
| Non-chlorhexidine bathing | Other | Patients in an ICU randomized to treatment arm 2 will be bathed with single use, no rinse, disposable cloths that do not contain chlorhexidine gluconate solution (Sage Comfort Bath® Cleansing Washcloths). Bathing of the skin of the arms, chest, abdomen, back, both legs, perineum, and buttocks will be performed daily and as needed after patients become soiled. The face and neck will not be bathed in this manner but will be bathed with water-moistened washcloths. All other infection control and cleaning procedures will be performed per the current protocols in each intensive care unit. |
|
Skin reactions related to topical chlorhexidine |
| As needed |
| Hospital mortality | Hospital mortality | One year |
| Hospital length of stay | Hospital length of stay | One year |
| ICU length of stay | ICU length of stay | One year |
| Rate of cultures positive for multi-drug resistant organisms | Daily |
| Rates of blood culture contamination | Daily |
| Rates of healthcare-acquired bloodstream infections | Daily |
| D013568 |
| Pathological Conditions, Signs and Symptoms |