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

NCT01090479 | Completed Results DMC

• 1 other identifier: 2% Chlorhexidine Cloths
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-operative Surgical Site Infections

Keywords

Surgical site infections; Chlorhexidine; Shoulder surgery

Outcome Measures

Primary Outcomes (1)

• Number of Patients With a Clinically Diagnosed Infection

  2 months post-operatively

Secondary Outcomes (1)

• Qualitative and Quantitative Bacterial Cultures of the Operative Shoulder Just Prior to Surgery

  7 days

Study Arms (2)

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.

Drug: 2% Chlorhexidine cloth

Interventions

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.

2% Chlorhexidine cloth

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient undergoing shoulder surgery (open or arthroscopic)

You may not qualify if:

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

Sponsors & Collaborators

• Northwestern University: lead
• Sage Products, Inc.: collaborator

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (2)

• 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.

  PMID: 21612945 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.

  PMID: 19651954 DERIVED

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

No specific limitations other than the study was underpowered to detect a difference in the clinical infection rate between the chlorhexidine and control groups.

Results Point of Contact

• Title: Michael Murray, MD
• Organization: Northwestern University

m.murray8278@gmail.com

312-926-4444

Study Officials

• Gordon Nuber, M.D.

  Professor of Orthopaedic Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Orthopaedics

Study Record Dates

• First Submitted: March 18, 2010
• First Posted: March 22, 2010
• Study Start: January 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: October 1, 2010
• Last Updated: May 23, 2023
• Results First Posted: August 14, 2012

Record last verified: 2023-04

Locations

US (1)