Pre-operative Preparation Using 2% Chlorhexidine Cloth For Shoulder Surgery

NCT ID: NCT01090479

Last Updated: 2023-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2010-10-31

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).

Conditions

Post-operative Surgical Site Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Control

This group will perform an ordinary shower the night prior and the morning of their scheduled surgery date.

Group Type: NO_INTERVENTION

No interventions assigned to this group

2% Chlorhexidine cloth

This group will use the 2% chlorhexidine wipes the night prior as well as the morning of their surgery date.

Group Type: EXPERIMENTAL

2% Chlorhexidine cloth

Intervention Type: DRUG

The 2% Chlorhexidine cloth will be applied to the operative extremity the night prior and the the morning of their surgery.

Interventions

2% Chlorhexidine cloth

The 2% Chlorhexidine cloth will be applied to the operative extremity the night prior and the the morning of their surgery.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sage Products, Inc.

INDUSTRY

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Gordon Nuber

Professor of Orthopaedics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gordon Nuber, M.D.

Role: PRINCIPAL_INVESTIGATOR

Professor of Orthopaedic Surgery

Locations

Northwestern Memorial Hospital

Chicago, Illinois, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 21612945 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 19651954 (View on PubMed)

Other Identifiers

2% Chlorhexidine Cloths

Identifier Type: -

Identifier Source: org_study_id

NCT00829023

Identifier Type: -

Identifier Source: nct_alias