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

• ClinicalTrials.gov Identifier: NCT01640925
• Recruitment Status: Completed
• First Posted: July 16, 2012
• Results First Posted: May 22, 2015
• Last Update Posted: April 27, 2018
• Sponsor: Joshua Swan
• Collaborators: Texas Southern University; The Methodist Hospital Research Institute
• Information provided by (Responsible Party): Joshua Swan, The Methodist Hospital Research Institute

Study Description

Brief 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).

Condition or disease	Intervention/treatment	Phase
Cross Infection; Pneumonia, Ventilator-associated; Catheter-related Infections; Infection Due to Indwelling Urinary Catheter; Surgical Wound Infection	Drug: Chlorhexidine gluconate; Other: Standard bathing	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 350 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Randomized Controlled Trial of 2% Chlorhexidine Bathing on Nosocomial Infections in the Surgical Intensive Care Unit
• Study Start Date: July 2012
• Actual Primary Completion Date: May 2013
• Actual Study Completion Date: September 2014

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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.	Drug: Chlorhexidine gluconate; Chlorhexidine gluconate 2% solution applied topically for full body bathing once every 48 hours; Other Name: Bactoshield 4%
Placebo Comparator: Standard bathing; Upon study enrollment, patients will be bathed using standard bathing (non-medicated cloths or soap and water) daily.	Other: Standard bathing; The patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily.

Outcome Measures

Primary Outcome Measures :

1. Incidence of Nosocomial Infection [ Time Frame: 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 Outcome Measures :

1. Incidence of Skin Irritation [ Time Frame: 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.
2. ICU Length of Stay in Days [ Time Frame: up to 28 days ]
   Number of days in the ICU after enrollment in study until first ICU discharge.
3. Number of Patients With In-hospital Mortality [ Time Frame: up to 28 days or until first hospital discharge ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Texas

Surgical Intensive Care Unit, The Methodist Hospital

Houston, Texas, United States, 77030

Sponsors and Collaborators

Joshua Swan

Texas Southern University

The Methodist Hospital Research Institute

Investigators

• Principal Investigator: Joshua T Swan, Pharm.D.; The Methodist Hospital, Texas Southern University

More Information

Publications of Results:

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.

• Responsible Party: Joshua Swan, Sponsor-Investigator/Principal Investigator, The Methodist Hospital Research Institute
• ClinicalTrials.gov Identifier: NCT01640925
• Other Study ID Numbers: Pro00006876; 1211-0239 ( Other Identifier: HMRI IRB )
• First Posted: July 16, 2012
• Results First Posted: May 22, 2015
• Last Update Posted: April 27, 2018
• Last Verified: March 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: Plan to share data to be determined.

Keywords provided by Joshua Swan, The Methodist Hospital Research Institute:

nosocomial infection; hospital acquired infection; chlorhexidine; pneumonia, ventilator-associated; catheter-related infections; urinary tract infections, catheter-related; surgical site infection

Additional relevant MeSH terms:

Infections; Communicable Diseases; Pneumonia; Wound Infection; Surgical Wound Infection; Cross Infection; Catheter-Related Infections; Pneumonia, Ventilator-Associated; Surgical Wound; Disease Attributes; Pathologic Processes; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Wounds and Injuries; Postoperative Complications; Iatrogenic Disease; Healthcare-Associated Pneumonia; Chlorhexidine; Chlorhexidine gluconate; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Dermatologic Agents