← Back to Search

Antiseptic

Surgical Antiseptic Reapplication for Surgical Site Infection

Phase 4
Waitlist Available
Led By Kyle T Judd, MD
Research Sponsored by Sanford Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Both elective and non-elective procedures
Be older than 18 years old
Must not have
Pregnant (to be assessed the day of surgery per standard of care surgical protocol)
Multiple planned lower extremity surgeries
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14-21 days
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

Summary

This trial is testing whether re-applying a surgical prep solution to the skin before surgery can help reduce the risk of infection.

Who is the study for?
This trial is for adults over 18 who have had lower extremity surgery below the knee and need a splint for 2-3 weeks. Participants must understand English and give informed consent. It's not for pregnant individuals, those allergic to chlorhexidine gluconate or isopropyl alcohol, with multiple surgeries planned, skin diseases, infections at the surgical site, open wounds, or unable to meet study requirements.
What is being tested?
The study tests if reapplying Chloraprep antiseptic after lower leg surgery reduces bacterial contamination and infection risk. The goal is to see if this can help prevent infections during early healing in high-risk patients.
What are the potential side effects?
Potential side effects may include skin reactions due to sensitivity or allergy to ingredients in Chloraprep such as chlorhexidine gluconate or isopropyl alcohol.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am open to both planned and emergency medical procedures.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not pregnant.
Select...
I am scheduled for multiple surgeries on my legs.
Select...
I have a skin condition affecting only certain areas.
Select...
I have open wounds or skin abrasions.
Select...
I have an infection at the site where I will have surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14-21 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14-21 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
positive culture rate
quantitative bacterial colonization
Secondary study objectives
bacterial strain identification

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
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.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: reapplicationExperimental Treatment1 Intervention
This group will have chloraprep reapplied following their lower extremity surgical procedure and prior to dressing application.
Group II: no reapplicationActive Control1 Intervention
This group will not have chloraprep reapplied after their surgery and prior to dressing application.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chlorhexidine
FDA approved

Find a Location

Who is running the clinical trial?

Sanford HealthLead Sponsor
50 Previous Clinical Trials
66,811 Total Patients Enrolled
Kyle T Judd, MDPrincipal InvestigatorSanford Orthopedics and Sports Medicine

Media Library

Chloraprep (Antiseptic) Clinical Trial Eligibility Overview. Trial Name: NCT02017145 — Phase 4
Bacterial Colonization Research Study Groups: reapplication, no reapplication
Bacterial Colonization Clinical Trial 2023: Chloraprep Highlights & Side Effects. Trial Name: NCT02017145 — Phase 4
Chloraprep (Antiseptic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02017145 — Phase 4
~12 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top