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Skin Preparation for Foot and Ankle Surgery
Phase 4
Recruiting
Research Sponsored by University of Missouri-Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
patients undergoing elective foot and ankle surgeries
age over 18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights
Study Summary
This trial will compare the rate of surgical site infections in patients who receive a pre-scrub with isopropyl alcohol and chlorhexidine soap to those who only receive the standard of care skin preparation with iodine or chlorhexidine solution.
Who is the study for?
This trial is for adults over 18 years old who are scheduled for elective foot and ankle surgeries. It's not suitable for those with trauma-related surgery, non-elective procedures, pregnant individuals, prior infections at the surgical site, open injuries, or amputations.Check my eligibility
What is being tested?
The study tests if additional skin cleaning with isopropyl alcohol and chlorhexidine soap before standard iodine or chlorhexidine preparation can reduce microbial load and prevent infections in elective foot and ankle surgeries.See study design
What are the potential side effects?
Possible side effects may include skin irritation or allergic reactions to the antiseptic agents used (isopropyl alcohol or chlorhexidine). These could manifest as redness, itching, or rash at the application site.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for elective foot or ankle surgery.
Select...
I am over 18 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Surgical Site Infection
Secondary outcome measures
Microbial Load
Trial Design
2Treatment groups
Active Control
Group I: Iodine or Chlorhexidine PreparationActive Control1 Intervention
Standard of care with only skin preparation of iodine or chlorhexidine solution prior to sterile draping before surgery.
Group II: Iodine or Chlorhexidine Scrub Brush Pre-Scrub with Isopropyl Alcohol and Chlorhexidine SoapActive Control2 Interventions
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).
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Who is running the clinical trial?
University of Missouri-ColumbiaLead Sponsor
362 Previous Clinical Trials
628,014 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My surgery is due to an injury.I have had an infection in a previous surgery area.I am not pregnant or have confirmed it following the standard protocol.I have open wounds.I am scheduled for elective foot or ankle surgery.I am over 18 years old.I have not had any unplanned medical procedures.I have had an amputation.
Research Study Groups:
This trial has the following groups:- Group 1: Iodine or Chlorhexidine Preparation
- Group 2: Iodine or Chlorhexidine Scrub Brush Pre-Scrub with Isopropyl Alcohol and Chlorhexidine Soap
Awards:
This trial has 5 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What dangers do Iodine or Chlorhexidine Preparation present to individuals?
"The safety of Iodine or Chlorhexidine Preparation was rated as a 3, signifying that this treatment has been approved and is safe to use."
Answered by AI
Are there still spots available to join this medical research project?
"Affirmative. Evidence on clinicaltrials.gov suggests that this investigation, which was originally published in February 15th 2022 is actively recruiting volunteers. A total of 100 individuals will be accepted from a single site."
Answered by AI
What is the participant cap for this research project?
"Affirmative, the information on clinicaltrials.gov illustrates that patient recruitment for this medical trial is still ongoing. It was initially posted on February 15th 2022 and has been amended as recently as May 27th 2022. The study hopes to recruit 100 people at one location."
Answered by AI
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