Efficacy of Surgical Preparation Solutions in Knee Surgery

Completed · Not applicable

Conditions studied: Arthroplasty, Replacement

In brief

The goal of this study is to determine the superiority of surgical scrub preparations in total knee arthroplasty based on the bacterial counts present on the skin surface and in the deep joint tissues. These counts will be obtained by culturing the skin prior to any scrub preparation, post preparation after the application of the sterile drapes, deep joint tissue sample prior to wound closure, and immediately post wound closure. This study will provide an assessment of the management of sterility by comparing quantitative and qualitative cultures immediately after surgical scrub preparation and the maintenance of sterility throughout the procedure. This study will enhance prior research efforts by contributing quantitative bacterial load and bacterial load within the surgical wound at closure.

Key facts

Study ID

NCT01857349

Run by

Texas Tech University Health Sciences Center

People needed

77

Starts

2013-04-01

Expected to finish

2020-07-20

Last updated by the study team

2020-10-20

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• >18 years old and less than 89
• Undergoing primary total knee arthroplasty
• Not undergoing surgical intervention for infection

You may not qualify if…

• Injury due to trauma
• Open wound at the incision site determined by pre-op history and physical
• Abrasion in the vicinity of the planned incision site determined by pre-op history and physical
• Active infection at or near the surgical incision site determined by pre-op history and physical
• Active infection somewhere else in the body determined by pre-op labs and history and physical
• Prior history of surgical infection or bacteremia determined by pre-op history and physical
• History of rheumatoid arthritis determined by pre-op history and physical
• History of autoimmune disorder determined by pre-op history and physical
• Immunosuppressed patient determined by pre-op history and physical
• Known allergy to iodine, isopropyl alcohol or Chlorhexidine

Where it is running

• Texas Tech University Health Science Center Orthopaedic Surgery — Lubbock, Texas, United States

Full record on ClinicalTrials.gov

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