Pre-operative Alcohol Skin Solutions in Fractured Extremities

Summary

The prevention of infection is an important goal influencing peri-operative care of extremity fracture patients. Standard practice in the operative management of extremity 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 extremity fracture surgery.

Conditions

• Surgical Site Infection
• Unplanned Fracture-Related Reoperation
• Open Appendicular Fracture
• Closed Lower Extremity Fracture
• Pelvic Fracture

Interventions

DRUG

DuraPrep

The iodine-based treatment intervention is an antiseptic solution comprised of iodine povacrylex (0.7% free iodine) in 74% isopropyl alcohol. 3M™ DuraPrep™ \[3M Health Care, St Paul, MN\], will be the commercial product used.

DRUG

ChloraPrep

The CHG intervention is an antiseptic solution comprised of 2% CHG in 70% isopropyl alcohol. ChloraPrep® \[CareFusion Inc., Leawood, KS, USA\] will be the product used.

Sponsors & Collaborators

• McMaster University

  collaborator OTHER

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• 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

2018-08-21

Primary Completion

2023-03-15

Completion

2024-02-02

FDA Drug

Yes

Countries

• United States
• Canada

Study Locations