Pre-operative Aqueous Antiseptic Skin Solutions in Open Fractures

Phase 4

Completed

• Conditions: Open Appendicular Fracture; Unplanned Fracture-Related Reoperation; Surgical Site Infection
• Interventions: Drug: 10% povidone-iodine (1% free iodine) in purified water; Drug: 4% chlorhexidine gluconate (CHG) in purified water

• Registration Number: NCT03385304
• Lead Sponsor: University of Maryland, Baltimore

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-20
• Study First Submitted QC: 2017-12-20
• Study First Posted: 2017-12-28
• Study Start: 2018-04-08
• Primary Completion: 2021-10-19
• Study Completion: 2022-06-27
• Results First Submitted: 2022-11-15
• Status Verified: 2023-03
• Results First Submitted QC: 2023-03-06
• Last Update Submitted: 2023-03-06
• Results First Posted: 2023-03-31
• Last Update Posted: 2023-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1638

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
10% povidone-iodine (1% free iodine) in purified water	10% povidone-iodine (1% free iodine) in purified water	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.).
10% povidone-iodine (1% free iodine) in purified water	4% chlorhexidine gluconate (CHG) in purified water	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.).
4% chlorhexidine gluconate (CHG) in purified water	4% chlorhexidine gluconate (CHG) in purified water	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.).
4% chlorhexidine gluconate (CHG) in purified water	10% povidone-iodine (1% free iodine) in purified water	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.).

Primary Outcome Measures

Name	Time	Method
Number of Participants With a Deep Incisional or Organ/Space Infection	Within 90 days of the patient's last planned fracture management surgery	Guided by CDC's National Healthcare Safety Network Surgical Site Infection reporting criteria (2017): Deep Incisional Infection: Occurs within 90 days post definitive fracture management; \& involves fascial/muscle layers; \& has at least one of the following: 1. deep incision purulent drainage; 2. a deep incision that dehisces, or is opened by a surgeon, and organism is identified by microbiologic testing; or microbiologic testing is not performed \& has at least one of the following: fever (\> 38 °C); localized pain or tenderness; 3. other evidence of deep incision infection on anatomical exam or imaging test; Organ/Space Infection: Occurs within 90 days post definitive fracture management; \& involves any part of the body deeper than the fascial/muscle layers; \& has at least one of the following: 1. organ/space purulent drainage; 2. organisms in organ/space identified by microbiologic testing; 3. other evidence of organ/space infection on anatomical exam or imaging test
Number of Participants With a Superficial Incisional Surgical Site Infection (SSI)	Within 30 days of the patient's last planned fracture management surgery	Guided by the Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network reporting criteria (2017): Date of event for infection may occur from the date of fracture to 30 days after the definitive fracture management surgery; AND involves only skin and subcutaneous tissue of the incision; AND patient has at least one of the following: 1. purulent drainage from the superficial incision.; 2. organisms identified from an aseptically obtained specimen from the superficial incision or subcutaneous tissue by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment; 3. superficial incision that is deliberately opened by a surgeon, and culture or non-culture-based testing is not performed. AND patient has at least one of the following signs or symptoms: pain or tenderness; localized swelling; erythema; or heat.; 4. diagnosis of a superficial incisional SSI by the surgeon.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With an Unplanned Fracture-Related Reoperation	Within 12 months of the patient's last planned operation	Common examples include any unplanned fracture-related surgery that is associated with an infection at the operative site or contiguous to it, a wound-healing problem, or a fracture delayed union or non-union.

Trial Locations

Locations (15)

University of California San Francisco; 🇺🇸 San Francisco, California, United States

Indiana University Health Methodist Hospital; 🇺🇸 Indianapolis, Indiana, United States

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States

University of Maryland, R Adams Cowley Shock Trauma Center; 🇺🇸 Baltimore, Maryland, United States

Hospital Parc Tauli de Sabadell; 🇪🇸 Barcelona, Spain

Banner - University Medical Center Tucson; 🇺🇸 Tucson, Arizona, United States

Greenville Health System; 🇺🇸 Greenville, South Carolina, United States

San Antonio Military Medical Center; 🇺🇸 Fort Sam Houston, Texas, United States

McGovern Medical School at University of Texas Health Science Center Houston; 🇺🇸 Houston, Texas, United States

McMaster University, Center for Evidence-Based Orthopaedics; 🇨🇦 Hamilton, Ontario, Canada

Hamilton Health Sciences; 🇨🇦 Hamilton, Ontario, Canada

Vall d'Hebron University Hospital; 🇪🇸 Barcelona, Spain

Wright State University / Miami Valley Hospital; 🇺🇸 Dayton, Ohio, United States

The CORE Institute / Banner University Medical Center; 🇺🇸 Phoenix, Arizona, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States