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

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ClinicalTrials.gov Identifier: NCT01090479
Recruitment Status : Completed
First Posted : March 22, 2010
Results First Posted : August 14, 2012
Last Update Posted : May 6, 2013
Sponsor:
Collaborator:
Sage Products, Inc.
Information provided by (Responsible Party):
Gordon Nuber, Northwestern University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Post-operative Surgical Site Infections
Intervention Drug: 2% Chlorhexidine cloth
Enrollment 100
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control 2% Chlorhexidine Cloth
Hide Arm/Group 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.
Period Title: Overall Study
Started 50 50
Completed 50 50
Not Completed 0 0
Arm/Group Title Control 2% Chlorhexidine Cloth Total
Hide Arm/Group 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. Total of all reporting groups
Overall Number of Baseline Participants 50 50 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
46
  92.0%
43
  86.0%
89
  89.0%
>=65 years
4
   8.0%
7
  14.0%
11
  11.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 50 participants 100 participants
52.0  (8) 49.0  (9) 50.5  (7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Female
25
  50.0%
36
  72.0%
61
  61.0%
Male
25
  50.0%
14
  28.0%
39
  39.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 50 participants 50 participants 100 participants
50 50 100
1.Primary Outcome
Title Number of Patients With a Clinically Diagnosed Infection
Hide Description [Not Specified]
Time Frame 2 months post-operatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Chlorhexidine
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 50 50
Measure Type: Number
Unit of Measure: participants
0 0
2.Secondary Outcome
Title Qualitative and Quantitative Bacterial Cultures of the Operative Shoulder Just Prior to Surgery
Hide Description [Not Specified]
Time Frame 7 days
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control 2% Chlorhexidine Cloth
Hide Arm/Group 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.
All-Cause Mortality
Control 2% Chlorhexidine Cloth
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Control 2% Chlorhexidine Cloth
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/50 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control 2% Chlorhexidine Cloth
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/50 (0.00%) 
No specific limitations other than the study was underpowered to detect a difference in the clinical infection rate between the chlorhexidine and control groups.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Michael Murray, MD
Organization: Northwestern University
Phone: 312-926-4444
Responsible Party: Gordon Nuber, Northwestern University
ClinicalTrials.gov Identifier: NCT01090479     History of Changes
Other Study ID Numbers: 2% Chlorhexidine Cloths
First Submitted: March 18, 2010
First Posted: March 22, 2010
Results First Submitted: July 9, 2012
Results First Posted: August 14, 2012
Last Update Posted: May 6, 2013