Pre-operative Preparation Using 2% Chlorhexidine Cloth For 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Efficacy of Home Pre-Operative Use of 2% Chlorhexidine Cloths Prior to Shoulder Surgery|
- Number of Patients With a Clinically Diagnosed Infection [ Time Frame: 2 months post-operatively ] [ Designated as safety issue: No ]
- Qualitative and Quantitative Bacterial Cultures of the Operative Shoulder Just Prior to Surgery [ Time Frame: 7 days ] [ Designated as safety issue: No ]
|Study Start Date:||January 2010|
|Study Completion Date:||October 2010|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
No Intervention: Control
This group will perform an ordinary shower the night prior and the morning of their scheduled surgery date.
Experimental: 2% Chlorhexidine cloth
This group will use the 2% chlorhexidine wipes the night prior as well as the morning of their surgery date.
Drug: 2% Chlorhexidine cloth
The 2% Chlorhexidine cloth will be applied to the operative extremity the night prior and the the morning of their 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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01090479
|United States, Illinois|
|Northwestern Memorial Hospital|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Gordon Nuber, M.D.||Professor of Orthopaedic Surgery|