Skin Preparation for Elective Foot and Ankle Surgery

University of Missouri (MU)

Status and phase: Enrolling; Phase 4

Conditions: Foot and Ankle Disorders; Microbial Colonization

Treatments: Drug: Isopropyl Alcohol 70% Topical Application Solution; Drug: Hibiclens

Study type: Interventional

Funder types: Other

Identifiers

NCT05401292

2074962

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Iodine or Chlorhexidine Preparation

Active Comparator group

Description:

Standard of care with only skin preparation of iodine or chlorhexidine solution prior to sterile draping before surgery.

Treatment:

Drug: Hibiclens

Iodine or Chlorhexidine Scrub Brush Pre-Scrub with Isopropyl Alcohol and Chlorhexidine Soap

Active Comparator group

Description:

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).

Treatment:

Drug: Hibiclens

Drug: Isopropyl Alcohol 70% Topical Application Solution