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| ID | Type | Description | Link |
|---|---|---|---|
| 1211-0239 | Other Identifier | HMRI IRB |
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| Name | Class |
|---|---|
| Texas Southern University | OTHER |
| The Methodist Hospital Research Institute | OTHER |
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This prospective, randomized, controlled trial will compare the incidence of nosocomial infections (composite of primary bloodstream infections, catheter-associated urinary tract infections, ventilator-associated pneumonia, and surgical site infections) that occur in intensive care unit (ICU) patients bathed with 2% chlorhexidine solution versus patients who receive standard bathing (soap and water or non-medicated cloths).
Upon study enrollment, patients will be randomized to one of two study arms. Patients in study arm one will receive standard bathing (soap and water or non-medicated cloth) daily. Patients in study arm two will receive a 2% chlorhexidine bath on study day 1 and every 48 hours and a standard bath (soap and water or non-medicated cloths) on study day 2 and every 48 hours. Patients will be followed until ICU day 28 or discharged from the surgical ICU.
Hypothesis: Compared to standard daily bathing, chlorhexidine-based bathing on ICU admission and every 48 hours will decrease the incidence of nosocomial infections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chlorhexidine gluconate bathing | Active Comparator | Upon study enrollment, patients will be bathed with a 2% chlorhexidine gluconate solution on study day 1 and every 48 hours until study completion. The patient will be bathed using standard bathing (non-medicated cloths or soap and water) on study day 2 and every 48 hours after that. |
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| Standard bathing | Placebo Comparator | Upon study enrollment, patients will be bathed using standard bathing (non-medicated cloths or soap and water) daily. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhexidine gluconate | Drug | Chlorhexidine gluconate 2% solution applied topically for full body bathing once every 48 hours |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Nosocomial Infection | Proportion of patients with one or more incident nosocomial infections. Primary Efficacy Endpoints* (Composite of new nosocomial infection)
(*)Diagnosed using the Centers for Disease Control criteria for hospital acquired infections. Only infections that develop 48 hours or more after study enrollment will be counted as primary endpoints. (**)Ventilator associated pneumonia is defined as pneumonia that developed after 48 hours of mechanical ventilation. | Up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Skin Irritation | The incidence of new onset skin irritation will be recorded and graded for severity using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.03. | up to 28 days |
| ICU Length of Stay in Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joshua T Swan, Pharm.D. | The Methodist Hospital, Texas Southern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Surgical Intensive Care Unit, The Methodist Hospital | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Swan JT, Bui LN, Pham VP, Shirkey BA, Graviss EA, Hai SA, Ashton CM, Wray NP. "RCT of chlorhexidine versus soap & water bathing for prevention of hospital-acquired infections in SICU". Critical Care Medicine. 2014;42(12 supplement):abstract 4. | ||
| 27428384 | Result | Swan JT, Ashton CM, Bui LN, Pham VP, Shirkey BA, Blackshear JE, Bersamin JB, Pomer RM, Johnson ML, Magtoto AD, Butler MO, Tran SK, Sanchez LR, Patel JG, Ochoa RA Jr, Hai SA, Denison KI, Graviss EA, Wray NP. Effect of Chlorhexidine Bathing Every Other Day on Prevention of Hospital-Acquired Infections in the Surgical ICU: A Single-Center, Randomized Controlled Trial. Crit Care Med. 2016 Oct;44(10):1822-32. doi: 10.1097/CCM.0000000000001820. |
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Plan to share data to be determined.
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| ID | Title | Description |
|---|---|---|
| FG000 | Chlorhexidine Gluconate Bathing | Upon study enrollment, patients will be bathed with a 2% chlorhexidine gluconate solution on study day 1 and every 48 hours until study completion. The patient will be bathed using standard bathing (non-medicated cloths or soap and water) on study day 2 and every 48 hours after that. Chlorhexidine gluconate: Chlorhexidine gluconate 2% solution applied topically for full body bathing once every 48 hours |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Standard bathing | Other | The patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily. |
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Number of days in the ICU after enrollment in study until first ICU discharge.
| up to 28 days |
| Number of Patients With In-hospital Mortality | up to 28 days or until first hospital discharge |
| FG001 | Standard Bathing | Upon study enrollment, patients will be bathed using standard bathing (non-medicated cloths or soap and water) daily. Standard bathing: The patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Chlorhexidine Gluconate Bathing | Upon study enrollment, patients will be bathed with a 2% chlorhexidine gluconate solution on study day 1 and every 48 hours until study completion. The patient will be bathed using standard bathing (non-medicated cloths or soap and water) on study day 2 and every 48 hours after that. Chlorhexidine gluconate: Chlorhexidine gluconate 2% solution applied topically for full body bathing once every 48 hours |
| BG001 | Standard Bathing | Upon study enrollment, patients will be bathed using standard bathing (non-medicated cloths or soap and water) daily. Standard bathing: The patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| 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 | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Incidence of Nosocomial Infection | Proportion of patients with one or more incident nosocomial infections. Primary Efficacy Endpoints* (Composite of new nosocomial infection)
(*)Diagnosed using the Centers for Disease Control criteria for hospital acquired infections. Only infections that develop 48 hours or more after study enrollment will be counted as primary endpoints. (**)Ventilator associated pneumonia is defined as pneumonia that developed after 48 hours of mechanical ventilation. | Posted | Number | participants | Up to 28 days |
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| Secondary | Incidence of Skin Irritation | The incidence of new onset skin irritation will be recorded and graded for severity using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.03. | Posted | Count of Participants | Participants | up to 28 days |
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| Secondary | ICU Length of Stay in Days | Number of days in the ICU after enrollment in study until first ICU discharge. | Posted | Mean | Standard Deviation | days | up to 28 days |
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| Secondary | Number of Patients With In-hospital Mortality | Posted | Count of Participants | Participants | up to 28 days or until first hospital discharge |
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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 | Chlorhexidine Gluconate Bathing | Upon study enrollment, patients will be bathed with a 2% chlorhexidine gluconate solution on study day 1 and every 48 hours until study completion. The patient will be bathed using standard bathing (non-medicated cloths or soap and water) on study day 2 and every 48 hours after that. Chlorhexidine gluconate: Chlorhexidine gluconate 2% solution applied topically for full body bathing once every 48 hours | 1 | 161 | 30 | 161 | ||
| EG001 | Standard Bathing | Upon study enrollment, patients will be bathed using standard bathing (non-medicated cloths or soap and water) daily. Standard bathing: The patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily. | 0 | 164 | 31 | 164 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Grade 3 Adverse Skin Occurence | Skin and subcutaneous tissue disorders | NCI CTCAE v4.03 | Systematic Assessment | One severe (grade 3) skin occurrence was detected in the chlorhexidine arm; however, a blinded reviewer determined that this was due to an allergic reaction to a systemic penicillin antibiotic and was not related to full-body bathing. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Incident adverse skin occurrence | Skin and subcutaneous tissue disorders | NCI CTCAE v4.03 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joshua Swan | Houston Methodist Hospital | 713-441-0165 | jtswan@houstonmethodist.org |
| ID | Term |
|---|---|
| D003428 | Cross Infection |
| D053717 | Pneumonia, Ventilator-Associated |
| D055499 | Catheter-Related Infections |
| D013530 | Surgical Wound Infection |
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000077299 | Healthcare-Associated Pneumonia |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D014946 | Wound Infection |
| D011183 | Postoperative Complications |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C010882 | chlorhexidine gluconate |
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| Male |
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