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| Name | Class |
|---|---|
| Sage Products, Inc. | INDUSTRY |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2% Chlorhexidine cloth | Drug | The 2% Chlorhexidine cloth will be applied to the operative extremity the night prior and the the morning of their surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With a Clinically Diagnosed Infection | 2 months post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gordon Nuber, M.D. | Professor of Orthopaedic Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21612945 | Derived | 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. | |
| 19651954 | Derived | Saltzman 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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| ID | Title | Description |
|---|---|---|
| FG000 | Control | This group will perform an ordinary shower the night prior and the morning of their scheduled surgery date. |
| FG001 | 2% Chlorhexidine Cloth | This group will use the 2% chlorhexidine wipes the night prior as well as the morning of their surgery date. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | This group will perform an ordinary shower the night prior and the morning of their scheduled surgery date. |
| BG001 | 2% Chlorhexidine Cloth | This group will use the 2% chlorhexidine wipes the night prior as well as the morning of their surgery date. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With a Clinically Diagnosed Infection | Posted | Number | participants | 2 months post-operatively |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | This group will perform an ordinary shower the night prior and the morning of their scheduled surgery date. |
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No specific limitations other than the study was underpowered to detect a difference in the clinical infection rate between the chlorhexidine and control groups.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Murray, MD | Northwestern University | 312-926-4444 | m.murray8278@gmail.com |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | 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) | Rate of positive cultures from entire shoulder region (combined from axilla and posterior shoulder) | Posted | Number | percentage of participants | 7 days |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | 2% Chlorhexidine Cloth | This group will use the 2% chlorhexidine wipes the night prior as well as the morning of their surgery date. | 0 | 50 | 0 | 50 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |