Post-operative Surgical Site InfectionsNCT01090479
Pre-operative Preparation Using 2% Chlorhexidine Cloth For Shoulder Surgery
A study testing 2% Chlorhexidine cloth in people with Post-operative Surgical Site Infections, run by Northwestern University at 1 site in United States.
Trial summary
We intend to determine how effective the use of a 2% Chlorhexidine Cloth is in terms of eliminating the bacterial load on patients undergoing shoulder surgery. We will be comparing the Chlorhexidine Cloths with a control group which will be performing an ordinary shower prior to surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-operative Surgical Site Infections
- What is being tested?
- 2% Chlorhexidine cloth
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Oct 2010
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient undergoing shoulder surgery (open or arthroscopic)
Who cannot join
- Patient unwilling to comply with instructions
- Active infection in the operative extremity
- Documented allergic reaction to chlorhexidine
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
Official title: Efficacy of Home Pre-Operative Use of 2% Chlorhexidine Cloths Prior to Shoulder Surgery
We intend to determine how effective the use of a 2% Chlorhexidine Cloth is in terms of eliminating the bacterial load on patients undergoing shoulder surgery. We will be comparing the Chlorhexidine Cloths with a control group which will be performing an ordinary shower prior to surgery. At this time, it is standard of care to only take an ordinary shower the evening prior, and the morning of surgery.
Read the detailed description
The use of home preoperative chlorhexidine wash has been used in various surgical fields for the prevention of perioperative infections. However, it's use in shoulder surgery has not been published up to this point. The shoulder has a unique microbial flora due to the prevalence of Propionibacterium acnes, a bacteria implicated in surgical site infections after shoulder surgery. This study is designed to examine the efficacy of using a preoperative Sage 2% chlorhexidine cloth in reducing bacterial load in the pre-operative area as well as in reducing post-operative surgical site infections after shoulder surgery. This study will compare the rate of post-operative infections and also the rate of positive skin cultures. The skin cultures will be obtained in the preoperative area from subjects who used the Sage 2% Chlorhexidine cloth protocol pre-operatively (n=50) versus those who used only soap and water (n=50).
- Conditions
- Post-operative Surgical Site Infections
- Being tested
- 2% Chlorhexidine cloth
- Keywords
- Surgical site infections, Chlorhexidine, Shoulder surgery
- 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 clothDrug
The 2% Chlorhexidine cloth will be applied to the operative extremity the night prior and the the morning of their surgery.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | This group will perform an ordinary shower the night prior and the morning of their scheduled surgery date. |
| 2% Chlorhexidine cloth | Experimental | This group will use the 2% chlorhexidine wipes the night prior as well as the morning of their surgery date. Receives: Drug: 2% Chlorhexidine cloth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With a Clinically Diagnosed Infection
Measured: 2 months post-operatively
Secondary outcomes (1)
Qualitative and Quantitative Bacterial Cultures of the Operative Shoulder Just Prior to Surgery
Rate of positive cultures from entire shoulder region (combined from axilla and posterior shoulder)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2010 (estimated)
- Study startJan 2010
- Primary completionAug 2010
- Study completionOct 2010
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 Post-operative Surgical Site InfectionsStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Sage Products, Inc.
- Responsible party
- Principal investigator, Gordon Nuber, Northwestern University
- Investigators
- Gordon Nuber, M.D., Principal investigator, Professor of Orthopaedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01090479
- Sponsor's protocol ID
- 2% Chlorhexidine Cloths
- Status last verified
- Apr 2023
- First submitted
- 18 Mar 2010
- Last updated
- 23 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Murray MR, Saltzman MD, Gryzlo SM, Terry MA, Woodward CC, Nuber GW. Efficacy of preoperative home use of 2% chlorhexidine gluconate cloth before shoulder surgery. J Shoulder Elbow Surg. 2011 Sep;20(6):928-33. doi: 10.1016/j.jse.2011.02.018. Epub 2011 May 25.
PubMed 21612945Saltzman MD, Nuber GW, Gryzlo SM, Marecek GS, Koh JL. Efficacy of surgical preparation solutions in shoulder surgery. J Bone Joint Surg Am. 2009 Aug;91(8):1949-53. doi: 10.2106/JBJS.H.00768.
PubMed 19651954
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Home Pre-Operative Use of 2% Chlorhexidine Cloths Prior to Shoulder Surgery
- ClinicalTrials.gov ID
- NCT01090479
- Acronym / sponsor ID
- 2% Chlorhexidine Cloths
- Conditions
- Post-operative Surgical Site Infections
- Keywords
- Surgical site infections, Chlorhexidine, Shoulder surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Sage Products, Inc.
- Study start
- Jan 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 22 Mar 2010 (estimated)
- Results
- Posted 14 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We intend to determine how effective the use of a 2% Chlorhexidine Cloth is in terms of eliminating the bacterial load on patients undergoing shoulder surgery. We will be comparing the Chlorhexidine Cloths with a control group which will be performing an ordinary shower prior to surgery. At this time, it is standard of care to only take an ordinary shower the evening prior, and the morning of surgery.
Detailed description
The use of home preoperative chlorhexidine wash has been used in various surgical fields for the prevention of perioperative infections. However, it's use in shoulder surgery has not been published up to this point. The shoulder has a unique microbial flora due to the prevalence of Propionibacterium acnes, a bacteria implicated in surgical site infections after shoulder surgery. This study is designed to examine the efficacy of using a preoperative Sage 2% chlorhexidine cloth in reducing bacterial load in the pre-operative area as well as in reducing post-operative surgical site infections after shoulder surgery. This study will compare the rate of post-operative infections and also the rate of positive skin cultures. The skin cultures will be obtained in the preoperative area from subjects who used the Sage 2% Chlorhexidine cloth protocol pre-operatively (n=50) versus those who used only soap and water (n=50).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –This group will perform an ordinary shower the night prior and the morning of their scheduled surgery date. |
| 2% Chlorhexidine cloth | Experimental | Drug: 2% Chlorhexidine clothThis group will use the 2% chlorhexidine wipes the night prior as well as the morning of their surgery date. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient undergoing shoulder surgery (open or arthroscopic)
Key exclusion criteria (3 listed)
- Patient unwilling to comply with instructions
- Active infection in the operative extremity
- Documented allergic reaction to chlorhexidine
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 clothThe 2% Chlorhexidine cloth will be applied to the operative extremity the night prior and the the morning of their surgery. | Drug | 2% Chlorhexidine cloth |
Primary outcome
Number of Patients With a Clinically Diagnosed Infection
Time frame: 2 months post-operatively
1 secondary outcome
Qualitative and Quantitative Bacterial Cultures of the Operative Shoulder Just Prior to Surgery
Time frame: 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21612945Murray MR, Saltzman MD, Gryzlo SM, Terry MA, Woodward CC, Nuber GW. Efficacy of preoperative home use of 2% chlorhexidine gluconate cloth before shoulder surgery. J Shoulder Elbow Surg. 2011 Sep;20(6):928-33. doi: 10.1016/j.jse.2011.02.018. Epub 2011 May 25.
- Derived from this study: PubMed 19651954Saltzman MD, Nuber GW, Gryzlo SM, Marecek GS, Koh JL. Efficacy of surgical preparation solutions in shoulder surgery. J Bone Joint Surg Am. 2009 Aug;91(8):1949-53. doi: 10.2106/JBJS.H.00768.
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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.
Gordon Nuber, M.D. principal investigator
Professor of Orthopaedic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2% Chlorhexidine cloth in people with Post-operative Surgical Site Infections, run by Northwestern University 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 1 inclusion and 3 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 23 May 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2012). 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?
Number of Patients With a Clinically Diagnosed Infection (time frame: 2 months post-operatively). 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 NCT01090479, 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 23 May 2023.