Nosocomial InfectionPhase 1NCT00130221
Skin Cleansing With Chlorhexidine to Decrease Hospital Acquired Infections
A Phase 1 study testing 2% chlorhexidine gluconate impregnated cloth and Daily bathing with Bar soap in people with Nosocomial Infection and Bacteremia, run by Cook County Health at 1 site in United States.
Trial summary
Patients in the intensive care unit are at risk for many infections because the severity of illness and the procedures necessary to care for them. This study is designed to look at a change in bathing procedure as a method to reduce infections. Currently, patients at John H. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Nosocomial Infection, Bacteremia, Sepsis
- What is being tested?
- 2% chlorhexidine gluconate impregnated cloth and Daily bathing with Bar soap
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to 26 Jul 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Data collection will be compiled from all the participants admitted to the Medical Intensive Care Unit (MICU).
- For skin cultures: One randomly selected (intubated or non-intubated) patient in each intervention group
Who cannot join
- Patients with greater than 20% of body surface area disruption in skin integrity will be excluded from participation in the 2% CHG Antiseptic Cloths arm of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
John H. Stroger Hospital of Cook County
Chicago, Illinois, 60612
About this study
Official title: Skin Cleansing With Chlorhexidine to Improve Nosocomial Infection Risks. (SCCIN Project)
Patients in the intensive care unit are at risk for many infections because the severity of illness and the procedures necessary to care for them. This study is designed to look at a change in bathing procedure as a method to reduce infections. Currently, patients at John H. Stroger Hospital are cleansed with soap and water. However, preliminary data from a previous study at Rush University Medical Center showed that a chlorhexidine (CHG)-impregnated cloth (2% CHG Antiseptic Cloth system, Sage Products, Inc.) decreased skin bacteria and may lessen bacteria in the blood stream. The 2% CHG Antiseptic Cloth system is a non-irritating, no-rinse, cleansing and moisturizing product that contains 2% chlorhexidine gluconate. The goal of this proposed study is to further evaluate the effectiveness of the 2% CHG Antiseptic Cloth system compared with soap and water in cleansing the skin and preventing bacteria from entering the bloodstream.
Read the detailed description
Patients admitted to the medical intensive care unit at John H Stroger Hospital are randomly assigned to Unit A or B. Unit B was randomly selected as the intervention unit. For 6 months, all patients in Unit B will be bathed with the 2% CHG Antiseptic Cloth system and all patients in Unit A will receive soap and water baths. After this 6 month period, there will be a 2 to 4 week washout period and the interventions will cross over, with Unit A receiving Chlorhexidine baths and unit B receiving soap and water for 6 months.
Each week, two randomly selected patients will have cultures of the inguinal area, neck/subclavian region, and endotracheal aspirates. A comparison of the colonization of the skin and sputum will be done between the two intervention groups.
Daily infection surveillance will be done on all patients in the intensive care unit. A comparison of blood stream infections, clinical sepsis, and other nosocomial infections will be done between the two intervention groups.
- Conditions
- Nosocomial Infection, Bacteremia, Sepsis, Pneumonia, Urinary Tract Infection, Clostridium Infection
- Being tested
- 2% chlorhexidine gluconate impregnated cloth, Daily bathing with Bar soap
- Keywords
- Chlorhexidine, Blood stream infections, central venous catheter associated, Nosocomial infection, Bacteremia, sepsis, Pneumonia, Urinary tract infection, Clostridium Difficile, intensive care unit, catheter, nosocomial pneumonia, Infection control
- Medical subject headings
- Cross Infection, Bacteremia, Sepsis, Pneumonia, Urinary Tract Infections, Clostridium Infections, Healthcare-Associated Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% chlorhexidine gluconate impregnated clothDrug
Daily bathing with Bar soapOther
Also called Soap
bathed daily with bar soap (Dial Corp., Scottsdale, AZ), warm water, and cotton washcloths.
| Study group | Role | What they receive |
|---|---|---|
| chlorhexidine gluconate (CHG) | Experimental | daily skin cleansing with no-rinse, 2% CHG-impregnated cloths (Sage) Receives: Drug: 2% chlorhexidine gluconate impregnated cloth |
| Soap & Water | Active comparator | bathing daily with bar soap (Dial Corp., Scottsdale, AZ) warm water, and cotton washcloths Receives: Other: Daily bathing with Bar soap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical: Primary blood stream infections and culture negative sepsis
Weekly culture of central line insertion sites
Measured: Six Months
Microbiologic: Skin colonization from environment and endotracheal secretions
Weekly skin cultures
Measured: Six Months
Secondary outcomes (2)
Clinical: Laboratory confirmed blood stream infections
Culture positive blood stream infection from patients on investigational units
Measured: Six months
Nosocomial infections
Positive microbiology lab results of Clostridium difficile-associated diarrhea (CDAD), secondary bloodstream infection (BSI), ventilator-associated pneumonia (VAP), urinary tract infection (UTI), and clinical cultures that grew selected resistant bacteria (MRSA, VRE, and A. baumannii).
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2005 (estimated)
- Study startJun 2005
- Primary completionJun 2006
- Study completion26 Jul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Nosocomial 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook County Health
- Sponsor type
- Other government
- Collaborators
- Sage Products, Inc., Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Pamela Gonzalez Sr Director Clinical Research Office, Cook County Health
- Investigators
- Robert A Weinstein, MD, Principal investigator, John H. Stroger Hospital of Cook County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00130221
- Sponsor's protocol ID
- 05-006
- Status last verified
- Jun 2023
- First submitted
- 12 Aug 2005
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Appelgren P, Hellstrom I, Weitzberg E, Soderlund V, Bindslev L, Ransjo U. Risk factors for nosocomial intensive care infection: a long-term prospective analysis. Acta Anaesthesiol Scand. 2001 Jul;45(6):710-9. doi: 10.1034/j.1399-6576.2001.045006710.x.
PubMed 11421829Beezhold DW, Slaughter S, Hayden MK, Matushek M, Nathan C, Trenholme GM, Weinstein RA. Skin colonization with vancomycin-resistant enterococci among hospitalized patients with bacteremia. Clin Infect Dis. 1997 Apr;24(4):704-6. doi: 10.1093/clind/24.4.704.
PubMed 9145745Cohen J, Cristofaro P, Carlet J, Opal S. New method of classifying infections in critically ill patients. Crit Care Med. 2004 Jul;32(7):1510-26. doi: 10.1097/01.ccm.0000129973.13104.2d.
PubMed 15241096Mermel LA, Farr BM, Sherertz RJ, Raad II, O'Grady N, Harris JS, Craven DE; Infectious Diseases Society of America; American College of Critical Care Medicine; Society for Healthcare Epidemiology of America. Guidelines for the management of intravascular catheter-related infections. Clin Infect Dis. 2001 May 1;32(9):1249-72. doi: 10.1086/320001. Epub 2001 Apr 3. No abstract available.
PubMed 11303260O'grady NP, Alexander M, Dellinger EP, Gerberding JL, Heard SO, Maki DG, Masur H, McCormick RD, Mermel LA, Pearson ML, Raad II, Randolph A, Weinstein RA; Healthcare Infection Control Practices Advisory Committee. Guidelines for the prevention of intravascular catheter-related infections. Am J Infect Control. 2002 Dec;30(8):476-89. doi: 10.1067/mic.2002.129427.
PubMed 12461511Shorr AF, Humphreys CW, Helman DL. New choices for central venous catheters: potential financial implications. Chest. 2003 Jul;124(1):275-84.
PubMed 12853534Bleasdale SC, Trick WE, Gonzalez IM, Lyles RD, Hayden MK, Weinstein RA. Effectiveness of chlorhexidine bathing to reduce catheter-associated bloodstream infections in medical intensive care unit patients. Arch Intern Med. 2007 Oct 22;167(19):2073-9. doi: 10.1001/archinte.167.19.2073.
PubMed 17954801
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Cleansing With Chlorhexidine to Improve Nosocomial Infection Risks. (SCCIN Project)
- ClinicalTrials.gov ID
- NCT00130221
- Acronym / sponsor ID
- 05-006
- Conditions
- Nosocomial Infection, Bacteremia, Sepsis, Pneumonia, Urinary Tract Infection, Clostridium Infection
- Keywords
- Chlorhexidine, Blood stream infections, central venous catheter associated, Nosocomial infection, Bacteremia, sepsis, Pneumonia, Urinary tract infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Cook County HealthOther government
- Collaborators
- Sage Products, Inc., Centers for Disease Control and Prevention
- Study start
- Jun 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- 26 Jul 2006 (actual)
- First posted
- 15 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients in the intensive care unit are at risk for many infections because the severity of illness and the procedures necessary to care for them. This study is designed to look at a change in bathing procedure as a method to reduce infections. Currently, patients at John H. Stroger Hospital are cleansed with soap and water. However, preliminary data from a previous study at Rush University Medical Center showed that a chlorhexidine (CHG)-impregnated cloth (2% CHG Antiseptic Cloth system, Sage Products, Inc.) decreased skin bacteria and may lessen bacteria in the blood stream. The 2% CHG Antiseptic Cloth system is a non-irritating, no-rinse, cleansing and moisturizing product that contains 2% chlorhexidine gluconate. The goal of this proposed study is to further evaluate the effectiveness of the 2% CHG Antiseptic Cloth system compared with soap and water in cleansing the skin and preventing bacteria from entering the bloodstream.
Detailed description
Patients admitted to the medical intensive care unit at John H Stroger Hospital are randomly assigned to Unit A or B. Unit B was randomly selected as the intervention unit. For 6 months, all patients in Unit B will be bathed with the 2% CHG Antiseptic Cloth system and all patients in Unit A will receive soap and water baths. After this 6 month period, there will be a 2 to 4 week washout period and the interventions will cross over, with Unit A receiving Chlorhexidine baths and unit B receiving soap and water for 6 months.
Each week, two randomly selected patients will have cultures of the inguinal area, neck/subclavian region, and endotracheal aspirates. A comparison of the colonization of the skin and sputum will be done between the two intervention groups.
Daily infection surveillance will be done on all patients in the intensive care unit. A comparison of blood stream infections, clinical sepsis, and other nosocomial infections will be done between the two intervention groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chlorhexidine gluconate (CHG) | Experimental | Drug: 2% chlorhexidine gluconate impregnated clothdaily skin cleansing with no-rinse, 2% CHG-impregnated cloths (Sage) |
| Soap & Water | Active comparator | Other: Daily bathing with Bar soapbathing daily with bar soap (Dial Corp., Scottsdale, AZ) warm water, and cotton washcloths |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Data collection will be compiled from all the participants admitted to the Medical Intensive Care Unit (MICU).
- For skin cultures: One randomly selected (intubated or non-intubated) patient in each intervention group
Key exclusion criteria (1 listed)
- Patients with greater than 20% of body surface area disruption in skin integrity will be excluded from participation in the 2% CHG Antiseptic Cloths arm of the study
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 |
|---|---|---|
| 2% chlorhexidine gluconate impregnated cloth | Drug | chlorhexidine gluconate (CHG) |
| Daily bathing with Bar soapAlso: Soapbathed daily with bar soap (Dial Corp., Scottsdale, AZ), warm water, and cotton washcloths. | Other | Soap & Water |
Primary outcome
Clinical: Primary blood stream infections and culture negative sepsis
Time frame: Six Months
Weekly culture of central line insertion sites
Microbiologic: Skin colonization from environment and endotracheal secretions
Time frame: Six Months
Weekly skin cultures
2 secondary outcomes
Clinical: Laboratory confirmed blood stream infections
Time frame: Six months
Nosocomial infections
Time frame: Six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Background: PubMed 11421829Appelgren P, Hellstrom I, Weitzberg E, Soderlund V, Bindslev L, Ransjo U. Risk factors for nosocomial intensive care infection: a long-term prospective analysis. Acta Anaesthesiol Scand. 2001 Jul;45(6):710-9. doi: 10.1034/j.1399-6576.2001.045006710.x.
- Background: PubMed 9145745Beezhold DW, Slaughter S, Hayden MK, Matushek M, Nathan C, Trenholme GM, Weinstein RA. Skin colonization with vancomycin-resistant enterococci among hospitalized patients with bacteremia. Clin Infect Dis. 1997 Apr;24(4):704-6. doi: 10.1093/clind/24.4.704.
- Background: PubMed 15241096Cohen J, Cristofaro P, Carlet J, Opal S. New method of classifying infections in critically ill patients. Crit Care Med. 2004 Jul;32(7):1510-26. doi: 10.1097/01.ccm.0000129973.13104.2d.
- Background: PubMed 11303260Mermel LA, Farr BM, Sherertz RJ, Raad II, O'Grady N, Harris JS, Craven DE; Infectious Diseases Society of America; American College of Critical Care Medicine; Society for Healthcare Epidemiology of America. Guidelines for the management of intravascular catheter-related infections. Clin Infect Dis. 2001 May 1;32(9):1249-72. doi: 10.1086/320001. Epub 2001 Apr 3. No abstract available.
- Background: PubMed 12461511O'grady NP, Alexander M, Dellinger EP, Gerberding JL, Heard SO, Maki DG, Masur H, McCormick RD, Mermel LA, Pearson ML, Raad II, Randolph A, Weinstein RA; Healthcare Infection Control Practices Advisory Committee. Guidelines for the prevention of intravascular catheter-related infections. Am J Infect Control. 2002 Dec;30(8):476-89. doi: 10.1067/mic.2002.129427.
- Background: PubMed 12853534Shorr AF, Humphreys CW, Helman DL. New choices for central venous catheters: potential financial implications. Chest. 2003 Jul;124(1):275-84.
- Derived from this study: PubMed 17954801Bleasdale SC, Trick WE, Gonzalez IM, Lyles RD, Hayden MK, Weinstein RA. Effectiveness of chlorhexidine bathing to reduce catheter-associated bloodstream infections in medical intensive care unit patients. Arch Intern Med. 2007 Oct 22;167(19):2073-9. doi: 10.1001/archinte.167.19.2073.
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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.
Robert A Weinstein, MD principal investigator
John H. Stroger Hospital of Cook County
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 2% chlorhexidine gluconate impregnated cloth and Daily bathing with Bar soap in people with Nosocomial Infection and Bacteremia, run by Cook County Health 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 1 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 18 Jun 2023. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical: Primary blood stream infections and culture negative sepsis (time frame: Six Months). The study lists 2 primary outcomes in all. 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 NCT00130221, which also lists 7 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 18 Jun 2023.