Visibility of Site Marking for Surgical Time Out With Two Different Skin Preparation Solutions

NCT00739583 | Completed Phase 4 Results

• 1 other identifier: NA_00011971
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Arthroplasty, Replacement, Hip

Keywords

Skin preparation; Skin marking; site marking; Site identification

Outcome Measures

Primary Outcomes (1)

• Identification of the Random Initials by the Reviewing Orthopaedic Surgeons

  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.

  at time of surgery, approximately 10 minutes

Secondary Outcomes (2)

• The Mean Change in Gray Level (Contrast) of the Horizontal Line

  at time of surgery, approximately ten minutes

• Judgment of Reviewing Orthopaedic Surgeons That the Site Marking is Identifiable for Them to Perform Site Identification

  at time of surgery, approximately ten minutes

Study Arms (2)

1

ACTIVE COMPARATOR

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

2

ACTIVE COMPARATOR

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

Interventions

CHG 2% w/v and IPA 70% v/v DRUG

Skin preparation of the surgical site per label of the product. The area for surgery will be prepared for 30 seconds

Also known as: Chloraprep® (CHG 2% w/v and IPA 70% v/v; Enturia Inc., Leawood, KS, USA)

1

Iodophor 0.7% and IPA 74% w/w DRUG

Skin preparation of the surgical site per product labeling. The area will be painted with the solution.

Also known as: Duraprep® (Iodophor 0.7% and IPA 74% w/w; 3M Healthcare, St. Paul, MN, USA)

2

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

• Mears SC, Dinah AF, Knight TA, Frassica FJ, Belkoff SM. Visibility of surgical site marking after preoperative skin preparation. Eplasty. 2008 Jul 16;8:e35.

  PMID: 18709136 BACKGROUND

MeSH Terms

Interventions

Chromogranins; Iodophors; DuraPrep; Delivery of Health Care

Intervention Hierarchy (Ancestors)

Nerve Tissue Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors; Iodine Compounds; Inorganic Chemicals; Patient Care Management; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

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

• Title: Simon C Mears
• Organization: Johns Hopkins University

smears1@jhmi.edu

410-550-0101

Study Officials

• Simon c Mears, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 20, 2008
• First Posted: August 21, 2008
• Study Start: August 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: July 10, 2013
• Results First Posted: July 10, 2013

Record last verified: 2013-06

Locations

US (1)