Visibility of Site Marking for Surgical Time Out With Two Different Skin Preparation Solutions (site marking)
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|ClinicalTrials.gov Identifier: NCT00739583|
Recruitment Status : Completed
First Posted : August 21, 2008
Results First Posted : July 10, 2013
Last Update Posted : July 10, 2013
Skin preparation solutions are used to clean the skin of the patient before surgery to decrease the rate of infection. This is particularly important for hip replacement to reduce the risk of prosthetic joint infection. The use of a mark on the skin for site identification has become the standard of care to decrease wrong site surgery. The Joint Commission has mandated site identification as part of the surgical "time-out". This procedure is also mandated by hospital policy.
Preliminary work on cadaveric skin shows that the type of skin preparation can erase the mark used for surgical site identification. Erasure of the mark presents the surgeon with difficulty in performing the site identification. Any error or lack of visualization of the site marking could lead to catastrophic wrong site surgery.
The investigators hypothesis is that chlorhexidine based skin preparation solutions erase site marking in comparison to iodine based skin preparation solutions. The investigators intend to prospectively study twenty patients undergoing total hip arthroplasty. Patients will be randomized to either a chlorhexidine based or an iodine based skin preparation solution. These solutions are both the current gold standard of clinical care. No differences have been shown in infection rates for total hip arthroplasty between these solutions. The site marking will be performed by the same surgeon in a standardized manner. The site marking will include the surgeon's three initials as per usual routine. Underneath the initials three random initials will be placed with a horizontal line drawn underneath. The preparation of the skin will be performed according to the manufacturer's specifications. Digital photographs will be taken of the skin marking after skin preparation. Photographs of the three random initials will be de-identified and placed in a "Powerpoint" presentation form. Ten orthopaedic surgeons will then read the site markings to identify the random initials and to tell whether the mark looks appropriate to perform a surgical timeout. The horizontal line will be digitally analyzed using Adobe Photoshop to quantitatively measure blackness of the mark.
|Condition or disease||Intervention/treatment||Phase|
|Arthroplasty, Replacement, Hip||Drug: CHG 2% w/v and IPA 70% v/v Drug: Iodophor 0.7% and IPA 74% w/w||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Visibility of Site Marking for Surgical Time Out With Two Different Skin Preparation Solutions|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||August 2009|
Active Comparator: 1
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)
Drug: CHG 2% w/v and IPA 70% v/v
Skin preparation of the surgical site per label of the product. The area for surgery will be prepared for 30 seconds
Other Name: Chloraprep® (CHG 2% w/v and IPA 70% v/v; Enturia Inc., Leawood, KS, USA)
Active Comparator: 2
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.
Drug: Iodophor 0.7% and IPA 74% w/w
Skin preparation of the surgical site per product labeling. The area will be painted with the solution.
Other Name: Duraprep® (Iodophor 0.7% and IPA 74% w/w; 3M Healthcare, St. Paul, MN, USA)
- Identification of the Random Initials by the Reviewing Orthopaedic Surgeons [ Time Frame: at time of surgery, approximately 10 minutes ]The number of correctly identified initials as viewed by the orthopaedic surgeons. 10 participants were randomized to each study group. Each patient was marked with three initials. Each was viewed by ten surgeons giving a total of 300 initials for each group.
- The Mean Change in Gray Level (Contrast) of the Horizontal Line [ Time Frame: at time of surgery, approximately ten minutes ]The Mean change in gray level of the ink line as expressed in units between pre and post skin preparation. Gray level is a unitless value from 0-255 describing the brightness of a pixel (0 being black and 255 being white).
- 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 ]The number of sets of initials judged by the viewing orthopedic surgeons as sufficient for adequate site identification. Each participant was labeled with three initials to simulate a surgeon's initials. Ten orthopaedic surgeons determined if the initials were visible enough to allow for site identification. Each surgeon viewed all of the sets of initials, resulting in 100 viewed sets of initials in each group.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00739583
|United States, Maryland|
|Johns Hopkins Bayview Medical Center|
|Baltimore, Maryland, United States, 21224|
|Principal Investigator:||Simon c Mears, MD, PhD||Johns Hopkins University|