Cross InfectionNCT01640925
Trial of 2% Chlorhexidine Bathing on Nosocomial Infections in the Surgical Intensive Care Unit
A study testing Chlorhexidine gluconate and Standard bathing in people with Cross Infection and Pneumonia, Ventilator-associated, run by Joshua Swan at 1 site in United States.
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%… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cross Infection, Pneumonia, Ventilator-associated, Catheter-related Infections
- What is being tested?
- Chlorhexidine gluconate and Standard bathing
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Sep 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Surgical Intensive Care Unit, The Methodist Hospital
Houston, Texas, 77030
About this study
Official title: Randomized Controlled Trial of 2% Chlorhexidine Bathing on Nosocomial Infections in the Surgical Intensive Care Unit
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).
Read the 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.
- Conditions
- Cross Infection, Pneumonia, Ventilator-associated, Catheter-related Infections, Infection Due to Indwelling Urinary Catheter, Surgical Wound Infection
- Being tested
- Chlorhexidine gluconate, Standard bathing
- Keywords
- nosocomial infection, hospital acquired infection, chlorhexidine, pneumonia, ventilator-associated, catheter-related infections, urinary tract infections, catheter-related, surgical site infection
- Medical subject headings
- Cross Infection, Pneumonia, Ventilator-Associated, Catheter-Related Infections, Surgical Wound Infection, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine gluconateDrug
Also called Bactoshield 4%
Chlorhexidine gluconate 2% solution applied topically for full body bathing once every 48 hours
Standard bathingOther
The patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard bathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 28 days
Secondary outcomes (3)
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.
Measured: up to 28 days
ICU Length of Stay in Days
Number of days in the ICU after enrollment in study until first ICU discharge.
Measured: up to 28 days
Number of Patients With In-hospital Mortality
Measured: up to 28 days or until first hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionMay 2013
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cross InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joshua Swan
- Sponsor type
- University, hospital or other
- Collaborators
- Texas Southern University, The Methodist Hospital Research Institute
- Responsible party
- Sponsor-investigator, Joshua Swan, The Methodist Hospital Research Institute
- Investigators
- Joshua T Swan, Pharm.D., Principal investigator, The Methodist Hospital, Texas Southern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01640925
- Sponsor's protocol ID
- Pro00006876
- Other IDs
- 1211-0239
- Status last verified
- Mar 2018
- First submitted
- 5 Jul 2012
- Last updated
- 27 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Plan to share data to be determined.
Publications
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.
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.
PubMed 27428384
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of 2% Chlorhexidine Bathing on Nosocomial Infections in the Surgical Intensive Care Unit
- ClinicalTrials.gov ID
- NCT01640925
- Acronym / sponsor ID
- Pro00006876
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Joshua SwanUniversity, hospital or other
- Collaborators
- Texas Southern University, The Methodist Hospital Research Institute
- Study start
- Jul 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 16 Jul 2012 (estimated)
- Results
- Posted 22 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine gluconate bathing | Active comparator | Drug: Chlorhexidine gluconateUpon 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. |
| Standard bathing | Placebo comparator | Other: Standard bathingUpon study enrollment, patients will be bathed using standard bathing (non-medicated cloths or soap and water) daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chlorhexidine gluconateAlso: Bactoshield 4%Chlorhexidine gluconate 2% solution applied topically for full body bathing once every 48 hours | Drug | Chlorhexidine gluconate bathing |
| Standard bathingThe patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily. | Other | Standard bathing |
Primary outcome
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.
3 secondary outcomes
Incidence of Skin Irritation
Time frame: up to 28 days
ICU Length of Stay in Days
Time frame: up to 28 days
Number of Patients With In-hospital Mortality
Time frame: up to 28 days or until first hospital discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationSwan 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 publication: PubMed 27428384Swan 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.
- Individual participant dataSharing planned: Undecided. Plan to share data to be determined.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua T Swan, Pharm.D. principal investigator
The Methodist Hospital, Texas Southern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chlorhexidine gluconate and Standard bathing in people with Cross Infection and Pneumonia, Ventilator-associated, run by Joshua Swan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Nosocomial Infection (time frame: Up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01640925, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2018.