Pre-operative Aqueous Antiseptic Skin Solutions in Open Fractures

PHASE4CompletedINTERVENTIONAL
Enrollment

1,638

Participants

Timeline

Start Date

April 8, 2018

Primary Completion Date

October 19, 2021

Study Completion Date

June 27, 2022

Conditions
Surgical Site InfectionUnplanned Fracture-Related ReoperationOpen 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.

Trial Locations (15)

21201

University of Maryland, R Adams Cowley Shock Trauma Center, Baltimore

29605

Greenville Health System, Greenville

32611

University of Florida, Gainesville

37240

Vanderbilt University, Nashville

45409

Wright State University / Miami Valley Hospital, Dayton

46202

Indiana University Health Methodist Hospital, Indianapolis

77030

McGovern Medical School at University of Texas Health Science Center Houston, Houston

78234

San Antonio Military Medical Center, Fort Sam Houston

85006

The CORE Institute / Banner University Medical Center, Phoenix

85721

Banner - University Medical Center Tucson, Tucson

94143

University of California San Francisco, San Francisco

L8L 2X2

Hamilton Health Sciences, Hamilton

L8L 8E7

McMaster University, Center for Evidence-Based Orthopaedics, Hamilton

Unknown

Hospital Parc Tauli de Sabadell, Barcelona

Vall d'Hebron University Hospital, Barcelona

All Listed Sponsors
collaborator

McMaster University

OTHER

collaborator

United States Department of Defense

FED

lead

University of Maryland, Baltimore

OTHER

NCT03385304 - Pre-operative Aqueous Antiseptic Skin Solutions in Open Fractures | Biotech Hunter | Biotech Hunter