RecruitingPhase 4NCT05401292

Skin Preparation for Elective Foot and Ankle Surgery


Sponsor

University of Missouri-Columbia

Enrollment

100 participants

Start Date

Feb 15, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Surgical site infections (SSIs) make about 31% of all nosocomial infections and they are the most common hospital-acquired infection. For foot and ankle elective interventions, SSI rate is reported between 0.4% and 3.6%. This study will investigate the effectiveness of skin cleaning with isopropyl alcohol and scrubbing with chlorhexidine soap before standard skin preparation in reducing microbial load and surgical site infections for elective foot and ankle surgeries. Current standard of care includes skin preparation with iodine or chlorhexidine solution prior to sterile draping and the start of surgery. Standard of care will be applied to all patients. The use of an additional "pre-scrub" with isopropyl alcohol and scrubbing with chlorhexidine soap will be applied to the experimental group. The control group will receive only the standard of care skin preparation with iodine or chlorhexidine solution prior to draping.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • patients undergoing elective foot and ankle surgeries
  • age over 18

Exclusion Criteria6

  • trauma as the indication for surgery
  • open injuries
  • non-elective procedures
  • amputations
  • prior surgical site infection through the planned incision
  • pregnancy. All potential participants of child-bearing potential follow the standard pre-operative protocol to ensure they are not in pregnant status prior to SOC surgical procedure.

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Interventions

DRUGHibiclens

antiseptic/antimicrobial skin cleanser for skin wound and general skin cleansing

DRUGIsopropyl Alcohol 70% Topical Application Solution

First aid antiseptic


Locations(1)

University of Missouri

Columbia, Missouri, United States

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NCT05401292


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