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4% chlorhexidine gluconate (CHG) in purified water for Surgical Site Infection (Aqueous-PREP Trial)
Phase 4
Waitlist Available
Led By Gerard Slobogean, MD
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients 18 years of age or older.
Received or will receive definitive fracture treatment with a surgical implant(s) (e.g., internal fixation, external fixation, joint prosthesis, etc.).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 30 days of the patient's last planned fracture management surgery
Awards & highlights
Aqueous-PREP Trial Summary
This trial is testing whether using iodine or chlorhexidine for skin preparation before surgery reduces the risk of infection for patients with open fractures.
Eligible Conditions
- Surgical Site Infection
- Fracture Reoperation
- Open Appendicular Fracture
Aqueous-PREP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowAqueous-PREP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 30 days of the patient's last planned fracture management surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 30 days of the patient's last planned fracture management surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With a Deep Incisional or Organ/Space Infection
Number of Participants With a Superficial Incisional Surgical Site Infection (SSI)
Secondary outcome measures
Number of Participants With an Unplanned Fracture-Related Reoperation
Side effects data
From 2022 Phase 4 trial • 1638 Patients • NCT0338530421%
Study Fracture Related Complication
11%
Other
3%
Pulmonary
3%
Non-Study Fracture Related Complication
1%
Cardiac
1%
Renal
1%
Gastro-Intestinal
1%
Neurological
1%
Vascular
100%
80%
60%
40%
20%
0%
Study treatment Arm
10% Povidone-iodine (1% Free Iodine) in Purified Water
4% Chlorhexidine Gluconate (CHG) in Purified Water
Aqueous-PREP Trial Design
2Treatment groups
Experimental Treatment
Group I: 4% chlorhexidine gluconate (CHG) in purified waterExperimental Treatment2 Interventions
The CHG solution will contain 4% CHG in purified water as the only active ingredient. Operating room personnel will apply the solution to the operative site as the final preoperative skin antisepsis preparation immediately prior to commencing surgical fixation. They will apply the solution as per manufacturer's directions (e.g., technique of application, duration of application, drying time, replacement of draping, etc.).
Group II: 10% povidone-iodine (1% free iodine) in purified waterExperimental Treatment2 Interventions
The povidone-iodine solution will contain 10% povidone-iodine (1% free iodine) in purified water as the only active ingredient. Operating room personnel will apply the solution to the operative site as the final preoperative skin antisepsis preparation immediately prior to commencing surgical fixation. They will apply the solution as per manufacturer's directions for use (e.g., technique of application, duration of application, drying time, drying techniques, replacement of draping, etc.).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chlorhexidine
FDA approved
Povidone-iodine
FDA approved
Find a Location
Who is running the clinical trial?
University of Maryland, BaltimoreLead Sponsor
687 Previous Clinical Trials
373,008 Total Patients Enrolled
United States Department of DefenseFED
861 Previous Clinical Trials
225,556 Total Patients Enrolled
McMaster UniversityOTHER
880 Previous Clinical Trials
2,596,190 Total Patients Enrolled
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