Skin Preparation for Elective Foot and Ankle Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Skin Preparation for Elective Foot and Ankle Surgery

Conditions
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Microbial Colonization, Foot and Ankle Disorders

Intervention / Treatment
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* Drug: Hibiclens
* Drug: Isopropyl Alcohol 70% Topical Application Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients undergoing elective foot and ankle surgeries age over 18 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Iodine or Chlorhexidine Preparation<br>Standard of care with only skin preparation of iodine or chlorhexidine solution prior to sterile draping before surgery. | Drug: Hibiclens<br>* antiseptic/antimicrobial skin cleanser for skin wound and general skin cleansing<br>|
| Active Comparator: Iodine or Chlorhexidine Scrub Brush Pre-Scrub with Isopropyl Alcohol and Chlorhexidine Soap<br>In addition to standard of care skin preparation with iodine or chlorhexidine solution prior to sterile draping, patients will also receive an additional pre-scrub with isopropyl alcohol and chlorhexidine soap. The operative extremity will be scrubbed for 2 minutes with chlorhexidine soap with a scrub brush until the entire extremity is covered. Isopropyl alcohol will then be wiped onto the skin with a gauze and allowed to evaporate (dry). | Drug: Hibiclens<br>* antiseptic/antimicrobial skin cleanser for skin wound and general skin cleansing<br>Drug: Isopropyl Alcohol 70% Topical Application Solution<br>* First aid antiseptic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbial Load | effectiveness of reducing microbial load. Comparing original microbial load to final microbial load (CFU/g) | 90 days |