Visibility of Site Marking for Surgical Time Out With Two Different Skin Preparation Solutions
Condition: Arthroplasty, Replacement, Hip
Intervention: CHG 2% w/v and IPA 70% v/v; Iodophor 0.7% and IPA 74% w/w
Intervention description: Skin preparation of the surgical site per label of the product. The area for surgery will be prepared for 30 seconds; Skin preparation of the surgical site per product labeling. The area will be painted with the solution.
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Skin preparation; Skin marking; site marking; Site identification

Summary:

      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.
    

Eligibility 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