Trials / Completed
CompletedNCT03385304
Pre-operative Aqueous Antiseptic Skin Solutions in Open Fractures
Aqueous-PREP: A Pragmatic Randomized Trial Evaluating Pre-operative Aqueous Antiseptic Skin Solutions in Open Fractures
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 1,638 (actual)
- Sponsor
- University of Maryland, Baltimore · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The prevention of infection is the single most important goal influencing peri-operative care of patients with open fractures. Standard practice in the management of open fractures includes sterile technique and pre-operative skin preparation with an antiseptic solution. The available solutions kill bacteria and decrease the quantity of native skin flora, thereby decreasing surgical site infection (SSI). While there is extensive guidance on specific procedures for prophylactic antibiotic use and standards for sterile technique, the evidence regarding the choice of antiseptic skin preparation solution is very limited for open fracture surgery.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 10% povidone-iodine (1% free iodine) in purified water | Participant recruitment will begin with the clinical sites using their assigned pre-operative antiseptic skin solution for all open fracture surgeries for a two-month period. |
| DRUG | 4% chlorhexidine gluconate (CHG) in purified water | Once the first intervention phase is completed, each site will crossover to the opposite study solution. Each site will need to develop local procedures to ensure a successful crossover. They will use the second solution for all open fracture surgeries for a two-month period, and will then crossover back to the solution in the first intervention phase. |
Timeline
- Start date
- 2018-04-08
- Primary completion
- 2021-10-19
- Completion
- 2022-06-27
- First posted
- 2017-12-28
- Last updated
- 2023-03-31
- Results posted
- 2023-03-31
Locations
15 sites across 3 countries: United States, Canada, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03385304. Inclusion in this directory is not an endorsement.