Visibility of Site Marking for Surgical Time Out With Two Different Skin Preparation Solutions (site marking)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Simon Mears, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00739583
First received: August 20, 2008
Last updated: June 5, 2013
Last verified: June 2013
Results First Received: March 9, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label
Condition: Arthroplasty, Replacement, Hip
Interventions: Drug: CHG 2% w/v and IPA 70% v/v
Drug: Iodophor 0.7% and IPA 74% w/w

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Chlorhexidine Group Skin preparation for hip replacement with a Chlorhexidine based skin preparation solution, Chloraprep® (CHG 2% w/v and IPA 70% v/v; Enturia Inc., Leawood, KS, USA)
Iodine Group Skin preparation for hip replacement with an Iodine based skin preparation solution, Duraprep® (Iodophor 0.7% and IPA 74% w/w; 3M Healthcare, St. Paul, MN, USA.

Participant Flow:   Overall Study
    Chlorhexidine Group     Iodine Group  
STARTED     10     10  
COMPLETED     10     10  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Chlorhexidine Group Skin preparation for hip replacement with a Chlorhexidine based skin preparation solution, Chloraprep® (CHG 2% w/v and IPA 70% v/v; Enturia Inc., Leawood, KS, USA)
Iodine Group Skin preparation for hip replacement with an Iodine based skin preparation solution, Duraprep® (Iodophor 0.7% and IPA 74% w/w; 3M Healthcare, St. Paul, MN, USA.
Total Total of all reporting groups

Baseline Measures
    Chlorhexidine Group     Iodine Group     Total  
Number of Participants  
[units: participants]
  10     10     20  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     4     3     7  
>=65 years     6     7     13  
Age  
[units: years]
Mean ± Standard Deviation
  71  ± 4.6     73  ± 4.2     72  ± 4.5  
Gender  
[units: participants]
     
Female     3     6     9  
Male     7     4     11  
Region of Enrollment  
[units: participants]
     
United States     10     10     20  



  Outcome Measures
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1.  Primary:   Identification of the Random Initials by the Reviewing Orthopaedic Surgeons   [ Time Frame: at time of surgery, approximately 10 minutes ]

2.  Secondary:   The Mean Change in Gray Level (Contrast) of the Horizontal Line   [ Time Frame: at time of surgery, approximately ten minutes ]

3.  Secondary:   Judgment of Reviewing Orthopaedic Surgeons That the Site Marking is Identifiable for Them to Perform Site Identification   [ Time Frame: at time of surgery, approximately ten minutes ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data

Non-standardization of the amount of ink used to mark each site.

The use of only one type of marking pen.

No measurement of the amount of pressure use to apply the skin cleaning solutions.

Potential subjectivity of surgeons viewing initials

 


Results Point of Contact:  
Name/Title: Simon C Mears
Organization: Johns Hopkins University
phone: 410-550-0101
e-mail: smears1@jhmi.edu


Publications:

Responsible Party: Simon Mears, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00739583     History of Changes
Other Study ID Numbers: NA_00011971
Study First Received: August 20, 2008
Results First Received: March 9, 2010
Last Updated: June 5, 2013
Health Authority: United States: Institutional Review Board