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
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Visibility of Site Marking for Surgical Time Out With Two Different Skin Preparation Solutions

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Identification of the Random Initials by the Reviewing Orthopaedic Surgeons [ Time Frame: at time of surgery, approximately 10 minutes ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • The Mean Change in Gray Level (Contrast) of the Horizontal Line [ Time Frame: at time of surgery, approximately ten minutes ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 20
Study Start Date: August 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • English speaking
  • Patients undergoing primary total hip surgery in a supine position.
  • Patients must be of light skin color
  • Patients must not be allergic to chlorhexidine or iodine

Exclusion Criteria:

  • Non English speaking
  • Patients not undergoing primary total hip surgery in a supine position.
  • Patients not of light skin color
  • Patients allergic to chlorhexidine or iodine
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00739583

Locations
United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Simon c Mears, MD, PhD Johns Hopkins University
  More Information

Publications:
Responsible Party: Simon Mears, Associate Professor, 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

Keywords provided by Johns Hopkins University:
Skin preparation
Skin marking
site marking
Site identification

Additional relevant MeSH terms:
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014