Skin Preparation for Elective Foot and Ankle Surgery

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Missouri-Columbia

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

patients undergoing elective foot and ankle surgeries

age over 18

Disqualifiers

trauma as the indication for surgery

open injuries

non-elective procedures

amputations

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hibiclens

    Drug

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

  • Isopropyl Alcohol 70% Topical Application Solution

    Drug

    First aid antiseptic

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Iodine or Chlorhexidine PreparationActive comparator 1 intervention
Group B: Iodine or Chlorhexidine Scrub Brush Pre-Scrub with Isopropyl Alcohol and Chlorhexidine SoapActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Surgical Site Infection

rate of surgical site infection (SSI) and wound complications following skin preparation for surgery. Measured by the number of surgical site infections in the total population of patients in the cohort

Time frame
90 days

Secondary outcomes

1

Microbial Load

effectiveness of reducing microbial load. Comparing original microbial load to final microbial load (CFU/g)

Time frame
90 days

Other outcomes

Sponsors and contacts

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