Randomized Controlled Trial of 2% Chlorhexidine Bathing on Nosocomial Infections in the Surgical Intensive Care Unit
| Registry | NCT01640925 |
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| Status | Completed |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, parallel, masking: none, prevention |
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| Enrollment | 350 (Actual) |
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| Sponsor | Joshua Swan (Other); collaborators: Texas Southern University, The Methodist Hospital Research Institute |
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| Conditions | Cross Infection, Pneumonia, Ventilator-associated, Catheter-related Infections, Infection Due to Indwelling Urinary Catheter, Surgical Wound Infection |
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| Interventions | Chlorhexidine gluconate, Standard bathing (Drug, other) |
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| Dates | start 2012-07-01, primary completion 2013-05-01, completion 2014-09-01, first posted 2012-07-16, last updated 2018-04-27 |
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| Locations | 1 site in United States |
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Related Papers Related Patents Related Grants Related Experts
All trials for Cross Infection All trials for Pneumonia, Ventilator-associated All trials of Chlorhexidine gluconate All trials of Standard bathing
-Summary
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).
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+Detailed description
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.
+Arms and interventions
| Arm | Type | Interventions | Description |
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| Chlorhexidine gluconate bathing | Active comparator | Drug: Chlorhexidine gluconate | 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. |
| Standard bathing | Placebo comparator | Other: Standard bathing | Upon study enrollment, patients will be bathed using standard bathing (non-medicated cloths or soap and water) daily. |
- Chlorhexidine gluconate (Drug), also known as Bactoshield 4%: Chlorhexidine gluconate 2% solution applied topically for full body bathing once every 48 hours
- Standard bathing (Other): The patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily.
+Outcome measures
Primary outcomes
- Incidence of Nosocomial Infection [Up to 28 days]: Proportion of patients with one or more incident nosocomial infections.
Primary Efficacy Endpoints* (Composite of new nosocomial infection)
* Primary Bloodstream Infection
* Catheter Related Urinary Tract Infection
* Ventilator-Associated Pneumonia**
* Surgical Site 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.
Secondary outcomes
- Incidence of Skin Irritation [up to 28 days]: 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.
- ICU Length of Stay in Days [up to 28 days]: Number of days in the ICU after enrollment in study until first ICU discharge.
- Number of Patients With In-hospital Mortality [up to 28 days or until first hospital discharge]
+Eligibility
Sex: All, ages: 18 Years to any
Inclusion Criteria:
* Admission to the surgical intensive care unit at The Methodist Hospital (Houston, TX)
* Anticipated surgical intensive care unit length of stay of 48 hours or more
Exclusion Criteria:
* Pregnancy
* Age less than 18 years old
* Braden score of less than 9 upon admission to the surgical intensive care unit
* Known allergy to chlorhexidine gluconate
* Active skin irritation upon admission to the surgical intensive care unit
+Posted results
Participant flow
| Milestone | Chlorhexidine Gluconate Bathing | Standard Bathing |
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| Started | 175 | 175 |
| Completed | 161 | 164 |
| Not completed | 14 | 11 |
Outcome results
- Incidence of Nosocomial Infection (Primary), Number, participants: Chlorhexidine Gluconate Bathing 15; Standard Bathing 30 (p 0.049)
- Incidence of Skin Irritation (Secondary), Count of participants, Participants: Chlorhexidine Gluconate Bathing 30; Standard Bathing 31
- ICU Length of Stay in Days (Secondary), Mean, days: Chlorhexidine Gluconate Bathing 7.2 +/- 11.4; Standard Bathing 7.0 +/- 8.6
- Number of Patients With In-hospital Mortality (Secondary), Count of participants, Participants: Chlorhexidine Gluconate Bathing 22; Standard Bathing 24
Adverse events
| Arm | Deaths | Serious adverse events | Other adverse events |
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| Chlorhexidine Gluconate Bathing | 0 | 1/161 (0.6%) | 30/161 (18.6%) |
| Standard Bathing | 0 | 0/164 (0.0%) | 31/164 (18.9%) |
Serious adverse events by term
| Term | Organ system | Chlorhexidine Gluconate Bathing | Standard Bathing |
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| Grade 3 Adverse Skin Occurence | Skin and subcutaneous tissue disorders | 1/161 | 0/164 |
Other adverse events by term
| Term | Organ system | Chlorhexidine Gluconate Bathing | Standard Bathing |
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| Incident adverse skin occurrence | Skin and subcutaneous tissue disorders | 30/161 | 31/164 |
+Locations (1)
| Facility | City | Country | Status |
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| Surgical Intensive Care Unit, The Methodist Hospital | Houston, Texas | United States | |
+Publications
- Results publication: 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.
- Results publication: 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. PMID 27428384
+Investigators