Clinical trial NCT01090479: Pre-operative Preparation Using 2% Chlorhexidine Cloth For Shoulder Surgery
Official title: Efficacy of Home Pre-Operative Use of 2% Chlorhexidine Cloths Prior to Shoulder Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-operative Surgical Site Infections
Keywords: Surgical site infections
Chlorhexidine
Shoulder surgery
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Sage Products, Inc.
First posted: 2010-03-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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).

Eligibility criteria: Inclusion Criteria:

* Patient undergoing shoulder surgery (open or arthroscopic)

Exclusion Criteria:

* Patient unwilling to comply with instructions
* Active infection in the operative extremity
* Documented allergic reaction to chlorhexidine

Primary outcomes:
measure: Number of Patients With a Clinically Diagnosed Infection
timeFrame: 2 months post-operatively
Secondary outcomes:
measure: Qualitative and Quantitative Bacterial Cultures of the Operative Shoulder Just Prior to Surgery
timeFrame: 7 days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Professor of Orthopaedic Surgery
name: Gordon Nuber, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.