← 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14-21 days
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
positive culture rate
quantitative bacterial colonization
Secondary outcome measures
bacterial strain identification

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
48 Previous Clinical Trials
61,783 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the U.S. Food and Drug Administration given its stamp of approval to Chloraprep?

"By our organization's standards, Chloraprep is rated a 3 as it has attained approval after going through its fourth phase of testing."

Answered by AI

How many participants does this experiment have capacity for?

"Unfortunately, the recruiting phase for this clinical trial has already concluded. The first post on 2/1/2014 and last update took place on 17th February 2014. Luckily, there are currently 71 trials in need of participants related to surgical antiseptic and 47 trials that use Chloraprep actively enrolling patients."

Answered by AI

Are recruitment efforts currently underway for this clinical trial?

"At this time, this trial is not open to participants. The original posting of the research was on February 1st 2014 and it has been last updated on February 17th 2014. Currently, 71 studies are actively seeking candidates for surgical antiseptic trials and 47 trials require patients for Chloraprep therapy."

Answered by AI

What other case studies have been conducted with Chloraprep?

"Currently, 47 trials related to Chloraprep are in progress with 18 of them reaching Phase 3. Most experiments using this drug take place in Phillip, Australian Capital Territory; however, 2768 sites across the globe have conducted studies for it."

Answered by AI

To what maladies does Chloraprep commonly provide relief?

"Chloraprep is typically used to ward off sepsis, but it also has applications in disinfection, sore throat management and pressure ulcer relief."

Answered by AI
~13 spots leftby Apr 2025