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临床试验/NCT00739583
NCT00739583已完成4 期

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

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2008年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
20
试验地点
1
主要终点
Identification of the Random Initials by the Reviewing Orthopaedic Surgeons

研究概览

简要总结

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.

详细描述

Abstract:

Skin preparation solutions are used to clean the skin of the patient before surgery to decrease the rate if 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. Our hypothesis is that chlorhexidine based skin preparation solutions erase site marking in comparison to iodine based skin marking solutions. We intend to prospectively study twenty patients undergoing total hip arthroplasty to determine if the site marking is erased by chlorhexidine based skin preparation solutions when compared to iodine based skin preparation solutions. This information is critical to all surgeons who must balance the risk of wound infection versus wrong site surgery.

Study Procedures:

We intend to study twenty patients of one orthopaedic surgeon (SCM) undergoing total hip replacement in the supine position. Patients must be English speaking and of light skin color to standardize the contrast of the site marking. The study will be discussed with the patient in the clinic setting before the surgical date. Patients will be randomized into either using a chlorhexidine based skin preparation solution (Chloraprep® (chlorhexidine gluconate 2% w/v and isopropyl alcohol 70% v/v; Enturia Inc., Leawood, KS, USA)), or an iodine based skin preparation solution (Duraprep® (Iodophor 0.7% and isopropyl alcohol 74% w/w; 3M Healthcare, St. Paul, MN, USA)). Patients with allergies to either chlorhexidine or iodine will not be included in the study. These solutions are both the current gold standard of clinical care and are routinely used in the Johns Hopkins Bayview Medical Center. No differences have been shown in infection rates for total hip arthroplasty between these solutions.

The site marking will be performed by the surgeon in a standardized manner using the standard marker supplied at the hospital (Sharpie Fine Point Permanent Marker, Sanford Corporation, Oak Brook, IL, USA). All markings will be made in the pre-operative holding area per usual routine. The site marking will be made next to the site of the incision on the anterior thigh. The site marking will include the surgeon's three initials as per usual routine. Underneath the surgeon's initials, three random initials will be placed with a horizontal line drawn underneath. Twenty random three-letter combinations will be pre-generated using MS Excel® (Microsoft Office 2003, Microsoft Corporation, Seattle WA).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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)

干预措施: CHG 2% w/v and IPA 70% v/v (Drug)

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.

干预措施: Iodophor 0.7% and IPA 74% w/w (Drug)

结局指标

主要结局

Identification of the Random Initials by the Reviewing Orthopaedic Surgeons

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Simon Mears

Associate Professor

Johns Hopkins University

研究点 (1)

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