Trial Outcomes & Findings for Trial of 2% Chlorhexidine Bathing on Nosocomial Infections in the Surgical Intensive Care Unit (NCT NCT01640925)
NCT ID: NCT01640925
Last Updated: 2018-04-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
350 participants
Primary outcome timeframe
Up to 28 days
Results posted on
2018-04-27
Participant Flow
Participant milestones
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
175
|
175
|
|
Overall Study
COMPLETED
|
161
|
164
|
|
Overall Study
NOT COMPLETED
|
14
|
11
|
Reasons for withdrawal
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Previously enrolled in this trial
|
13
|
11
|
Baseline Characteristics
Trial of 2% Chlorhexidine Bathing on Nosocomial Infections in the Surgical Intensive Care Unit
Baseline characteristics by cohort
| Measure |
Chlorhexidine Gluconate Bathing
n=161 Participants
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
|
Standard Bathing
n=164 Participants
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.
|
Total
n=325 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.4 years
STANDARD_DEVIATION 15.9 • n=39 Participants
|
60.2 years
STANDARD_DEVIATION 16.5 • n=41 Participants
|
59.8 years
STANDARD_DEVIATION 16.2 • n=35 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=39 Participants
|
78 Participants
n=41 Participants
|
141 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
98 Participants
n=39 Participants
|
86 Participants
n=41 Participants
|
184 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Up to 28 daysProportion 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.
Outcome measures
| Measure |
Chlorhexidine Gluconate Bathing
n=161 Participants
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
|
Standard Bathing
n=164 Participants
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.
|
|---|---|---|
|
Incidence of Nosocomial Infection
|
15 participants
|
30 participants
|
SECONDARY outcome
Timeframe: up to 28 daysThe 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.
Outcome measures
| Measure |
Chlorhexidine Gluconate Bathing
n=161 Participants
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
|
Standard Bathing
n=164 Participants
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.
|
|---|---|---|
|
Incidence of Skin Irritation
|
30 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: up to 28 daysNumber of days in the ICU after enrollment in study until first ICU discharge.
Outcome measures
| Measure |
Chlorhexidine Gluconate Bathing
n=161 Participants
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
|
Standard Bathing
n=164 Participants
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.
|
|---|---|---|
|
ICU Length of Stay in Days
|
7.2 days
Standard Deviation 11.4
|
7.0 days
Standard Deviation 8.6
|
SECONDARY outcome
Timeframe: up to 28 days or until first hospital dischargeOutcome measures
| Measure |
Chlorhexidine Gluconate Bathing
n=161 Participants
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
|
Standard Bathing
n=164 Participants
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.
|
|---|---|---|
|
Number of Patients With In-hospital Mortality
|
22 Participants
|
24 Participants
|
Adverse Events
Chlorhexidine Gluconate Bathing
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
Standard Bathing
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Chlorhexidine Gluconate Bathing
n=161 participants at risk
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
|
Standard Bathing
n=164 participants at risk
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.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Grade 3 Adverse Skin Occurence
|
0.62%
1/161 • Number of events 1
|
0.00%
0/164
|
Other adverse events
| Measure |
Chlorhexidine Gluconate Bathing
n=161 participants at risk
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
|
Standard Bathing
n=164 participants at risk
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.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Incident adverse skin occurrence
|
18.6%
30/161 • Number of events 43
|
18.9%
31/164 • Number of events 43
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place