Trial of 2% Chlorhexidine Bathing on Nosocomial Infections in the Surgical Intensive Care Unit

Surgical Wound Infection Clinical Trial

Official title:

Randomized Controlled Trial of 2% Chlorhexidine Bathing on Nosocomial Infections in the Surgical Intensive Care Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01640925
• Other study ID #: Pro00006876
• Secondary ID: 1211-0239
• Status: Completed
• Phase: N/A
• First received: July 5, 2012
• Last updated: March 27, 2018
• Start date: July 2012
• Est. completion date: September 2014

Study information

• Verified date: March 2018
• Source: The Methodist Hospital System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: September 2014
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Catheter-related Infections
• Communicable Diseases
• Cross Infection
• Infection
• Infection Due to Indwelling Urinary Catheter
• Pneumonia
• Pneumonia, Ventilator-associated
• Surgical Wound
• Surgical Wound Infection
• Wound Infection

Intervention

Drug:
• Chlorhexidine gluconate
Chlorhexidine gluconate 2% solution applied topically for full body bathing once every 48 hours

Other:
• Standard bathing
The patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily.

Locations

Country	Name	City	State
United States	Surgical Intensive Care Unit, The Methodist Hospital	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Joshua Swan	Texas Southern University, The Methodist Hospital System

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 — View Citation

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Nosocomial Infection	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.	Up to 28 days
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.	up to 28 days
Secondary	ICU Length of Stay in Days	Number of days in the ICU after enrollment in study until first ICU discharge.	up to 28 days
Secondary	Number of Patients With In-hospital Mortality		up to 28 days or until first hospital discharge