Pre-operative Aqueous Antiseptic Skin Solutions in Open Fractures

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

• Surgical Site Infection
• Unplanned Fracture-Related Reoperation
• Open Appendicular Fracture

Interventions

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.

Sponsors & Collaborators

• McMaster University

  collaborator OTHER

• United States Department of Defense

  collaborator FED

• University of Maryland, Baltimore

  lead OTHER

Principal Investigators

• Gerard Slobogean, MD · University of Maryland, Baltimore

• Sheila Sprague, PhD · McMaster University

• Mohit Bhandari, MD · McMaster University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-04-08

Primary Completion

2021-10-19

Completion

2022-06-27

FDA Drug

Yes

Countries

• United States
• Canada
• Spain

Study Locations