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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 below

Aqueous-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

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 30 days of the patient's last planned fracture management surgery for reporting.

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 • NCT03385304

21%

Study Fracture Related Complication

11%

Other

Pulmonary

Non-Study Fracture Related Complication

Cardiac

Renal

Gastro-Intestinal

Neurological

Vascular

100%

80%

60%

40%

20%

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

0 / 7Eligibility criteria met