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

Primary Purpose

Post-operative Surgical Site Infections

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

2% Chlorhexidine cloth

About this trial

This is an interventional prevention trial for Post-operative Surgical Site Infections focused on measuring Surgical site infections, Chlorhexidine, Shoulder surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Northwestern Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

2% Chlorhexidine cloth

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of Patients With a Clinically Diagnosed Infection

Secondary Outcome Measures

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)

Full Information

NCT ID

NCT01090479

First Posted

March 18, 2010

Last Updated

April 25, 2023

Sponsor

Northwestern University

Collaborators

Sage Products, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01090479

Brief Title

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

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

August 2010 (Actual)

Study Completion Date

October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

Collaborators

Sage Products, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post-operative Surgical Site Infections

Keywords

Surgical site infections, Chlorhexidine, Shoulder surgery

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

No Intervention

Arm Description

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

Arm Title

2% Chlorhexidine cloth

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

2% Chlorhexidine cloth

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of Patients With a Clinically Diagnosed Infection

Time Frame

2 months post-operatively

Secondary Outcome Measure Information:

Title

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

Description

Rate of positive cultures from entire shoulder region (combined from axilla and posterior shoulder)

Time Frame

7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gordon Nuber, M.D.

Organizational Affiliation

Professor of Orthopaedic Surgery

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northwestern Memorial Hospital

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

21612945

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.

Results Reference

derived

PubMed Identifier

19651954

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.

Results Reference

derived

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

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