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Visibility of Surgical Site Marking: A Prospective Randomized Trial of Two Skin Preparation Solutions
Savyasachi C. Thakkar, MD1; Simon C. Mears, MD, PhD1
1 c/o Elaine P. Henze, BJ, ELS, Medical Editor and Director, Editorial Services, Department of Orthopaedic Surgery, Johns Hopkins Bayview Medical Center, 4940 Eastern Avenue, #A665, Baltimore, MD 21224-2780. E-mail address: ehenze1@jhmi.edu
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Investigation performed at the Department of Orthopaedic Surgery, Johns Hopkins Bayview Medical Center, Baltimore, Maryland

A commentary by J. Lawrence Marsh, MD, is linked to the online version of this article at jbjs.org



Disclosure: One or more of the authors received payments or services, either directly or indirectly (i.e., via his or her institution), from a third party in support of an aspect of this work. None of the authors, or their institution(s), have had any financial relationship, in the thirty-six months prior to submission of this work, with an entity in the biomedical arena that could be perceived to influence or have the potential to influence what is written in this work. Also, no author has had any other relationships, or has engaged in any other activities, that could be perceived to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitted by authors are always provided with the online version of the article.

Copyright © 2012 by The Journal of Bone and Joint Surgery, Inc.
J Bone Joint Surg Am, 2012 Jan 18;94(2):97-102. doi: 10.2106/JBJS.J.00838
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Abstract

Background: 

An important component of the surgical time-out is to confirm surgical site skin markings to prevent wrong-site surgery. Different skin preparation solutions may have variable effects on the visibility of site markings after application. We performed a prospective randomized clinical trial to quantitatively and qualitatively evaluate the visibility of surgical site markings after the use of two commonly available skin preparation solutions.

Methods: 

We enrolled twenty patients undergoing primary total hip arthroplasty at our institution. Preoperatively, a black permanent marker was used to mark the skin of each patient with a random combination of three letters, underlined by a single black line, and with the surgeon's initials. Patients were randomly selected to receive a chlorhexidine-based or an iodine-based skin preparation according to manufacturer guidelines. The skin markings were photographed digitally, before and after the application of solution. The photographs made after the application of solution were assessed quantitatively, by calculating the contrast (marker to skin) before and after the application of the solutions, and qualitatively by ten orthopaedic surgeons to identify the random initials and to recognize skin markings.

Results: 

The mean change in contrast level after application of the chlorhexidine-based solution was significantly greater than that after application of the iodine-based solution (mean and standard deviation, 59.8 ± 15.7 U versus 14.9 ± 11.4 U, respectively; p < 0.0001). Surgeons were an average of twenty-two times less likely (95% confidence interval, eight to sixty-eight) to judge markings as acceptable for site identification after preparation with the chlorhexidine-based solution than after preparation with the iodine-based solution. When examining individual letters, the surgeons correctly identified 296 of 300 letters in the group prepared with the iodine-based solution and 209 of 300 letters in the group prepared with the chlorhexidine-based solution; the difference was significant (p < 0.0001).

Conclusions: 

The use of the chlorhexidine-based solution for skin preparation resulted in significantly greater erasure of the surgical site marking than did the use of the iodine-based solution.

Level of Evidence: 

Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

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    References

    Accreditation Statement
    These activities have been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the American Academy of Orthopaedic Surgeons and The Journal of Bone and Joint Surgery, Inc. The American Academy of Orthopaedic Surgeons is accredited by the ACCME to provide continuing medical education for physicians.
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    Andrew E Cattell, Philip J Roberts
    Posted on March 15, 2012
    Optimal Surgical Site Marking Visibility in Orthopaedic Surgery
    University Hospital of North Staffordshire

    Wrong site surgery remains one of the most feared orthopaedic complications, and hence surgical site marking that is visible within the draped field of surgery prior to the initial incision is an integral element of the time-out process. This study has built on previously published work in cadaveric specimens[1,2], and has demonstrated in vivo that chlorhexidine-based solutions decrease visibility of the mark compared to iodine-based solutions utilising 3 outcome methods. While this was a well-designed trial there are however some points of concern. Of the 54 patients initially assessed eligibility 63% (34 patients) were excluded. 14 were excluded for not meeting the inclusion criteria, however the only exclusion criteria stated was an allergy to either chlorhexidine or iodine. A further 20 patients declined to participate, but the particular reasons for this have not been stated. This level of exclusion seems relatively excessive considering the non-invasive nature of this trial. A further criticism is that only white patients were included in this trial, and hence the results cannot be extrapolated to darker skinned individuals. No trials currently exist that include this population group. Furthermore no specific parameters for acceptability were defined. In his commentary J. Lawrence Marsh[3] has pointed out a wrong site error can be prevented by skin marking regardless of its clarity, and does not necessarily need to be legible to fulfill its function as it merely marks the relevant limb and does not contain information pertaining to the actual procedure. Any degree of visibility should therefore be acceptable, and hence it can only be assumed that all evidence of the mark was eradicated in those deemed unacceptable by the study. I also note that on average with chlorhexidine-based solutions 2 of the 3 letters in the group were identifiable, which would imply a degree of acceptability in site identification. The number of cases in which all 3 letters were unidentifiable however has not been stated. This study did not specify the type of applicator or the total area prepared, both of which would affect marking site degradation. While both solutions were applied according to manufacturer based guidelines the standard chloraprep sponge applicator is designed to remove the outer layers of the epidermis to improve sterility and therefore would be likely to remove the marking ink by mechanical means irrespective of what solution was applied, and while Thakkar and Mears mention that the mechanism of site erasure was uncertain it would be logical to conclude that any rigorously applied solution (particularly alcohol based solutions) would cause a significant decrease in visibility of any applied mark. The chloraprep guidelines suggest that the surgical area is prepped for a total of 30 seconds, however if the applicator were applied to only the marked area a greater degree of mechanical degradation to the marking clarity would occur. The incision site is the most crucial area to be focused on, and as the marked site is traditionally distant to the incision site this further diminishes the mechanical exfoliating effect on the marker site. If this is indeed the case do the authors suggest that we change the type of pen we use? I note that an update to Mears et al’s [1,2] original cadaveric studies was published specifically evaluating chlorhexidine resistant marking pens[4]. These new inks did show a significantly improved visibility and contrast compared to regular markers, however confidence intervals never overlapped with those of iodine-based solutions. The authors concluded that while these new pens were an improvement further development was still required. In the only published randomized study comparing antiseptic solutions and their effect on wound infection Darouiche et al[5] demonstrated chlorhexidine to be superior to povidone-iodine in preventing both superficial and deep surgical site infections, and hence before we favor iodine over chlorhexidine we need to question whether it is the chlorhexidine itself that decreases marker visibility, or simply the application method used in this study. REFERENCES [1]Mears, S. C., Davani, A. B. & Belkoff, S. M. Does the type of skin marker prevent marking erasure of surgical-site markings? Eplasty 9, 2009;e36. [2]Mears, S. C., Dinah, A. F., Knight, T. A., Frassica, F. J. & Belkoff, S. M. Visibility of surgical site marking after preoperative skin preparation. Eplasty 8, 2008;e35. [3]Marsh, J. L. Reaching Optimal Clarity on Surgical Site Marking: Commentary on an article by Savyasachi C. Thakkar, MD, and Simon C. Mears, MD, PhD:Visibility of Surgical Site Marking: A Prospective Randomized Trial of Two Skin Preparation Solutions. JBJS (Am) 2012;94:e10-e11. [4]Marsland, D., Kamath, M. Y., Mears, S. C. & Belkoff, S. M. Letter to the editor, An Update: Does the Type of Skin Marker Prevent Marking Erasure of Surgical-Site Markings? Eplasty 2010;10:e50. [5]Darouiche, R. O., Wall Jr, M. J., Itani, K. M. F., Otterson, M. F., et al. Chlorhexidine--alcohol versus povidone--iodine for surgical-site antisepsis. NEJM 2010;362:18-26.

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