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

NCT01640925 | Completed Results

• 2 other identifiers: Pro000068761211-0239
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Incidence of Skin Irritation

  up to 28 days

• ICU Length of Stay in Days

  up to 28 days

• Number of Patients With In-hospital Mortality

  up to 28 days or until first hospital discharge

Study Arms (2)

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.

Drug: Chlorhexidine gluconate

Standard bathing

PLACEBO COMPARATOR

Upon study enrollment, patients will be bathed using standard bathing (non-medicated cloths or soap and water) daily.

Other: Standard bathing

Interventions

Chlorhexidine gluconate DRUG

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

Also known as: Bactoshield 4%

Chlorhexidine gluconate bathing

Standard bathing OTHER

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

Standard bathing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Joshua Swan: lead
• Texas Southern University: collaborator
• The Methodist Hospital Research Institute: collaborator

Study Sites (1)

Surgical Intensive Care Unit, The Methodist Hospital

Houston, Texas, 77030, United States

Location

Related Publications (2)

• 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.

  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.

  PMID: 27428384 RESULT

MeSH Terms

Conditions

Cross Infection; Pneumonia, Ventilator-Associated; Catheter-Related Infections; Surgical Wound Infection; Urinary Tract Infections

Interventions

chlorhexidine gluconate

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Healthcare-Associated Pneumonia; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Wound Infection; Postoperative Complications; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. Joshua Swan
• Organization: Houston Methodist Hospital

jtswan@houstonmethodist.org

713-441-0165

Study Officials

• Joshua T Swan, Pharm.D.

  The Methodist Hospital, Texas Southern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator/Principal Investigator

Study Record Dates

• First Submitted: July 5, 2012
• First Posted: July 16, 2012
• Study Start: July 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: September 1, 2014
• Last Updated: April 27, 2018
• Results First Posted: May 22, 2015

Record last verified: 2018-03

Locations

US (1)