search
Back to results

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

Primary Purpose

Cross Infection, Pneumonia, Ventilator-associated, Catheter-related Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chlorhexidine gluconate
Standard bathing
Sponsored by
Joshua Swan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cross Infection focused on measuring nosocomial infection, hospital acquired infection, chlorhexidine, pneumonia, ventilator-associated, catheter-related infections, urinary tract infections, catheter-related, surgical site infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Surgical Intensive Care Unit, The Methodist Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Chlorhexidine gluconate bathing

Standard bathing

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
ICU Length of Stay in Days
Number of days in the ICU after enrollment in study until first ICU discharge.
Number of Patients With In-hospital Mortality

Full Information

First Posted
July 5, 2012
Last Updated
March 27, 2018
Sponsor
Joshua Swan
Collaborators
Texas Southern University, The Methodist Hospital Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT01640925
Brief Title
Trial of 2% Chlorhexidine Bathing on Nosocomial Infections in the Surgical Intensive Care Unit
Official Title
Randomized Controlled Trial of 2% Chlorhexidine Bathing on Nosocomial Infections in the Surgical Intensive Care Unit
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Joshua Swan
Collaborators
Texas Southern University, The Methodist Hospital Research Institute

4. Oversight

Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
350 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chlorhexidine gluconate bathing
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard bathing
Arm Type
Placebo Comparator
Arm Description
Upon study enrollment, patients will be bathed using standard bathing (non-medicated cloths or soap and water) daily.
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine gluconate
Other Intervention Name(s)
Bactoshield 4%
Intervention Description
Chlorhexidine gluconate 2% solution applied topically for full body bathing once every 48 hours
Intervention Type
Other
Intervention Name(s)
Standard bathing
Intervention Description
The patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily.
Primary Outcome Measure Information:
Title
Incidence of Nosocomial Infection
Description
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.
Time Frame
Up to 28 days
Secondary Outcome Measure Information:
Title
Incidence of Skin Irritation
Description
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.
Time Frame
up to 28 days
Title
ICU Length of Stay in Days
Description
Number of days in the ICU after enrollment in study until first ICU discharge.
Time Frame
up to 28 days
Title
Number of Patients With In-hospital Mortality
Time Frame
up to 28 days or until first hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua T Swan, Pharm.D.
Organizational Affiliation
The Methodist Hospital, Texas Southern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Surgical Intensive Care Unit, The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Plan to share data to be determined.
Citations:
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.
Results Reference
result
PubMed Identifier
27428384
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs