Recruiting

Observational Study

Sponsor:

University of Missouri-Columbia

Code:

NCT05401292

Conditions

Microbial Colonization

Foot and Ankle Disorders

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hibiclens

Isopropyl Alcohol 70% Topical Application Solution

Study Details

Brief 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.

Conditions

Microbial Colonization

Foot and Ankle Disorders

Study ID

NCT05401292

Start date

Feb 15, 2022

Status verified date

Apr, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Iodine or Chlorhexidine Preparation

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

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

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).

Interventions

Hibiclens

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

Isopropyl Alcohol 70% Topical Application Solution

First aid antiseptic

Primary outcome measure

  • Surgical Site Infection [ Time Frame: 90 days ]

Central Contacts and Locations

Central contacts

Vicki L Jones, MEd, CCRP

5738827583jonesvicki@health.missouri.edu

Locations

University of Missouri

Recruiting

Columbia, Missouri, United States, 65211

Contacts

Vicki Jones, MEd, CCRP

573-882-7583jonesvicki@health.missouri.edu

Principal Investigator:

Kyle Schweser, MD

More Information

Sponsor

University of Missouri-Columbia

Last update posted

Apr 27, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Missouri-Columbia on 2026-04-27.