Surgical Site InfectionsERASENCT01425697
Eliminate Risk of Cardiac Surgical Site Events
A study testing 2% Chlorhexidine Gluconate cloths in people with Surgical Site Infections, run by University of Rochester at 4 sites in United States.
Trial summary
The purpose of the study is to see if using 2% Chlorhexidine cloths will reduce surgical site infections in patients having elective cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgical Site Infections
- What is being tested?
- 2% Chlorhexidine Gluconate cloths
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 739 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2008to Sep 2012
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elective cardiothoracic surgery patients > 18 years old.
- Informed consent obtained
Who cannot join
- Any current known allergies to chlorhexidine gluconate
- Currently taking any oral or topical antibiotics
- Any active skin rashes or breaks in the skin on areas to be treated with chlorhexidine gluconate
- A current active skin disease or inflammatory skin condition, known pre-existing skin infection, including contact dermatitis that is currently being treated with an antibiotic
- Any medical condition or use of any medications that in the opinion of the Principal Investigator preclude participation.
- Unwillingness or failure to fulfill requirements of the study
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Kentucky
Lexington, Kentucky
The Valley Hospital
Ridgewood, New Jersey
University of Rochester Medical Center
Rochester, New York, 14642
Robert Packer Hospital
Sayre, Pennsylvania
About this study
Official title: Randomized,Prospective Evaluation of 2% Chlorhexidine Gluconate Cloths to Reduce Surgical Site Infections in Cardiothoracic Surgery Patients
The purpose of the study is to see if using 2% Chlorhexidine cloths will reduce surgical site infections in patients having elective cardiac surgery.
Read the detailed description
A randomized, prospective study utilizing 2% Chlorhexidine cloths to evaluate the product's effectiveness in reducing surgical site infections in elective cardiothoracic surgery patients. Sage 2% chlorhexidine cloths are approved by the Food and Drug Administration (FDA) for preparation of skin prior to surgery.
The study hypothesis is that the preoperative surgical preparation with 2% chlorhexidine cloths, which leaves chlorhexidine on the skin, will reduce surgical site infections by 50% as compared to current standard procedure.
- Conditions
- Surgical Site Infections
- Being tested
- 2% Chlorhexidine Gluconate cloths, Standard of Care preoperative preparation.
- Keywords
- Adult Cardiac surgery, Surgery site infections
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% Chlorhexidine Gluconate clothsOther
2% chlorhexidine Gluconate wipes will bw used 12 hours prior to cardiac surgery and then again 3 hours prior to cardiac surgery. Subjects will be randomized to either receive a preoperative phone call reminder or no phone call reminder.
Standard of Care preoperative preparation.Other
Preoperative standard of care preparation utilized at the clinical site will be used. Subjects will be randomized to either receive a preoperative phone call reminder or no phone call reminder.
| Study group | Role | What they receive |
|---|---|---|
| 2% Chlorhexidine Gluconate cloths | Active comparator | 2% Chlorhexidine Gluconate wipes will be used 12 hours prior to cardiac surgery and then again 3 hours prior to cardiac surgery Receives: Other: 2% Chlorhexidine Gluconate cloths; Other: Standard of Care preoperative preparation. |
| Standard of Care Preoperative Preparation | Other | Subject will receive standard of care preoperative preparation for the clinical site. Receives: Other: 2% Chlorhexidine Gluconate cloths; Other: Standard of Care preoperative preparation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infections
Subjects will be assessed at 30 days and 90 days post operatively for any surgical site infection
Measured: Through 90 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2011 (estimated)
- Study startNov 2008
- Primary completionJul 2012
- Study completionSep 2012
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 Surgical Site InfectionsStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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
- 739 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Sage Products, Inc.
- Responsible party
- Principal investigator, Michael Ackerman, University of Rochester
- Investigators
- Michael Ackerman, DNS, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01425697
- Sponsor's protocol ID
- RSRB 25962
- Acronym
- ERASE
- Status last verified
- Jun 2013
- First submitted
- 22 Aug 2011
- Last updated
- 2 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
DeBaun B. Evaluation of the antimicrobial properties of an alcohol-free 2% chlorhexidine gluconate (CHG) solution. Poster, accepted for presentation at: 2007 Association of perioperative registered nurses (AORN) Congress, Orlando, FL Mar 2007
Ryder M. Improving Skin Antisepsis: 2% no-rinse CHG cloths improve antiseptic persistence on patient skin over 4% CHG rinse-off solution. Poster, accepted for presentation at:Association for Professionals in Infection Control and Epidemiology (APIC) June 2007
Edmiston CE Jr, Seabrook GR, Johnson CP, Paulson DS, Beausoleil CM. Comparative of a new and innovative 2% chlorhexidine gluconate-impregnated cloth with 4% chlorhexidine gluconate as topical antiseptic for preparation of the skin prior to surgery. Am J Infect Control. 2007 Mar;35(2):89-96. doi: 10.1016/j.ajic.2006.06.012.
PubMed 17327187Edmiston C, Seabrook GR, Johnson CP, et al. Comparison of a new and innovative 2% chlorhexidine gluconate (CHG) impregnated preparation cloth with the standard 4% CHG surgical skin preparation. Poster, accepted for presentation at: 2007 Association of perioperative Registered Nurses (AORN) Congress, Orlando, FL Mar 2007.
Eiselt D. Presurgical skin preparation with a novel 2% chlorhexidine gluconate (CHG) cloth leads to decrease in surgical site infection rates in orthopedic surgical patients. Poster accepted for presentation at: Association for Professionals in Infection Control and Epidemiology (APIC) June 2007.
Rhee H, Harris B. Reducing surgical site infection: 2% CHG cloth reduces SSI rates by >70% difference resulting in a $154,869 cost avoidance. Poster accepted for presentation at: Virginians Improving Patient Care and Safety (VIPC&S) 7th Annual Conference.
Berry AR, Watt B, Goldacre MJ, Thomson JW, McNair TJ. A comparison of the use of povidone-iodine and chlorhexidine in the prophylaxis of postoperative wound infection. J Hosp Infect. 1982 Mar;3(1):55-63. doi: 10.1016/0195-6701(82)90031-7. No abstract available.
PubMed 6177735
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized,Prospective Evaluation of 2% Chlorhexidine Gluconate Cloths to Reduce Surgical Site Infections in Cardiothoracic Surgery Patients
- ClinicalTrials.gov ID
- NCT01425697
- Acronym / sponsor ID
- ERASE / RSRB 25962
- Conditions
- Surgical Site Infections
- Keywords
- Adult Cardiac surgery, Surgery site infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 739 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Sage Products, Inc.
- Study start
- Nov 2008
- Primary completion
- Jul 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 30 Aug 2011 (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.
The purpose of the study is to see if using 2% Chlorhexidine cloths will reduce surgical site infections in patients having elective cardiac surgery.
Detailed description
A randomized, prospective study utilizing 2% Chlorhexidine cloths to evaluate the product's effectiveness in reducing surgical site infections in elective cardiothoracic surgery patients. Sage 2% chlorhexidine cloths are approved by the Food and Drug Administration (FDA) for preparation of skin prior to surgery.
The study hypothesis is that the preoperative surgical preparation with 2% chlorhexidine cloths, which leaves chlorhexidine on the skin, will reduce surgical site infections by 50% as compared to current standard procedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2% Chlorhexidine Gluconate cloths | Active comparator | Other: 2% Chlorhexidine Gluconate cloths, Other: Standard of Care preoperative preparation.2% Chlorhexidine Gluconate wipes will be used 12 hours prior to cardiac surgery and then again 3 hours prior to cardiac surgery |
| Standard of Care Preoperative Preparation | Other | Other: 2% Chlorhexidine Gluconate cloths, Other: Standard of Care preoperative preparation.Subject will receive standard of care preoperative preparation for the clinical site. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elective cardiothoracic surgery patients > 18 years old.
- Informed consent obtained
Key exclusion criteria (6 listed)
- Any current known allergies to chlorhexidine gluconate
- Currently taking any oral or topical antibiotics
- Any active skin rashes or breaks in the skin on areas to be treated with chlorhexidine gluconate
- A current active skin disease or inflammatory skin condition, known pre-existing skin infection, including contact dermatitis that is currently being treated with an antibiotic
- Any medical condition or use of any medications that in the opinion of the Principal Investigator preclude participation.
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 cloths2% chlorhexidine Gluconate wipes will bw used 12 hours prior to cardiac surgery and then again 3 hours prior to cardiac surgery. Subjects will be randomized to either receive a preoperative phone call reminder or no phone call reminder. | Other | 2% Chlorhexidine Gluconate cloths, Standard of Care Preoperative Preparation |
| Standard of Care preoperative preparation.Preoperative standard of care preparation utilized at the clinical site will be used. Subjects will be randomized to either receive a preoperative phone call reminder or no phone call reminder. | Other | 2% Chlorhexidine Gluconate cloths, Standard of Care Preoperative Preparation |
Primary outcome
Surgical site infections
Time frame: Through 90 days post procedure
Subjects will be assessed at 30 days and 90 days post operatively for any surgical site infection
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 2 Jul 2013.
- Results publicationDeBaun B. Evaluation of the antimicrobial properties of an alcohol-free 2% chlorhexidine gluconate (CHG) solution. Poster, accepted for presentation at: 2007 Association of perioperative registered nurses (AORN) Congress, Orlando, FL Mar 2007
- Results publicationRyder M. Improving Skin Antisepsis: 2% no-rinse CHG cloths improve antiseptic persistence on patient skin over 4% CHG rinse-off solution. Poster, accepted for presentation at:Association for Professionals in Infection Control and Epidemiology (APIC) June 2007
- Results publication: PubMed 17327187Edmiston CE Jr, Seabrook GR, Johnson CP, Paulson DS, Beausoleil CM. Comparative of a new and innovative 2% chlorhexidine gluconate-impregnated cloth with 4% chlorhexidine gluconate as topical antiseptic for preparation of the skin prior to surgery. Am J Infect Control. 2007 Mar;35(2):89-96. doi: 10.1016/j.ajic.2006.06.012.
- Results publicationEdmiston C, Seabrook GR, Johnson CP, et al. Comparison of a new and innovative 2% chlorhexidine gluconate (CHG) impregnated preparation cloth with the standard 4% CHG surgical skin preparation. Poster, accepted for presentation at: 2007 Association of perioperative Registered Nurses (AORN) Congress, Orlando, FL Mar 2007.
- Results publicationEiselt D. Presurgical skin preparation with a novel 2% chlorhexidine gluconate (CHG) cloth leads to decrease in surgical site infection rates in orthopedic surgical patients. Poster accepted for presentation at: Association for Professionals in Infection Control and Epidemiology (APIC) June 2007.
- Results publicationRhee H, Harris B. Reducing surgical site infection: 2% CHG cloth reduces SSI rates by >70% difference resulting in a $154,869 cost avoidance. Poster accepted for presentation at: Virginians Improving Patient Care and Safety (VIPC&S) 7th Annual Conference.
- Results publication: PubMed 6177735Berry AR, Watt B, Goldacre MJ, Thomson JW, McNair TJ. A comparison of the use of povidone-iodine and chlorhexidine in the prophylaxis of postoperative wound infection. J Hosp Infect. 1982 Mar;3(1):55-63. doi: 10.1016/0195-6701(82)90031-7. No abstract available.
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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.
Michael Ackerman, DNS principal investigator
University of Rochester
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2% Chlorhexidine Gluconate cloths in people with Surgical Site Infections, run by University of Rochester at 4 sites 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 6 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 2 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
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?
Surgical site infections (time frame: Through 90 days post procedure). 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 NCT01425697, 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 2 Jul 2013.