Pre-operative Aqueous Antiseptic Skin Solutions in Open Fractures

Surgical Site Infection Clinical Trial

— Aqueous-PREP  

Official title:

Aqueous-PREP: A Pragmatic Randomized Trial Evaluating Pre-operative Aqueous Antiseptic Skin Solutions in Open Fractures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03385304
• Other study ID #: HP-00078470
• Status: Completed
• Phase: Phase 4
• Start date: April 8, 2018
• Est. completion date: June 27, 2022

Study information

• Verified date: March 2023
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1638
• Est. completion date: June 27, 2022
• Est. primary completion date: October 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

The inclusion criteria are:

1. Patients 18 years of age or older.

2. Open fracture of the appendicular skeleton.

3. Received or will receive definitive fracture treatment with a surgical implant(s) (e.g., internal fixation, external fixation, joint prosthesis, etc.).

4. Open fracture wound management that includes formal surgical debridement within 72 hours of their injury.

5. Will have all planned fracture care surgeries performed by a participating surgeon or delegate.

6. Informed consent obtained.

7. Patient enrolled within 3 weeks of their fracture.

The exclusion criteria are:

1. Patients that did not or will not receive the allocated pre-operative surgical preparation solution due to a medical contraindication.

2. Received previous surgical debridement or management of their open fracture at a non-participating hospital or clinic.

3. Open fracture managed outside of the participating orthopaedic service (e.g., hand fracture managed by plastic surgeon).

4. Chronic or acute infection at or near the fracture site at the time of initial fracture surgery.

5. Burns at the fracture site.

6. Incarceration.

7. Expected injury survival of less than 90 days.

8. Terminal illness with expected survival less than 90 days.

9. Previous enrollment in a PREP-IT trial.

10. Currently enrolled in a study that does not permit co-enrollment.

11. Unable to obtain informed consent due to language barriers.

12. Likely problems, in the judgment of study personnel, with maintaining follow-up with the patient.

13. Excluded due to sampling strategy.

Related Conditions & MeSH terms

• Fractures, Bone
• Fractures, Open
• Open Appendicular Fracture
• Surgical Site Infection
• Surgical Wound Infection
• Unplanned Fracture-Related Reoperation

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences	Hamilton	Ontario
Canada	McMaster University, Center for Evidence-Based Orthopaedics	Hamilton	Ontario
Spain	Hospital Parc Tauli de Sabadell	Barcelona
Spain	Vall d'Hebron University Hospital	Barcelona
United States	University of Maryland, R Adams Cowley Shock Trauma Center	Baltimore	Maryland
United States	Wright State University / Miami Valley Hospital	Dayton	Ohio
United States	San Antonio Military Medical Center	Fort Sam Houston	Texas
United States	University of Florida	Gainesville	Florida
United States	Greenville Health System	Greenville	South Carolina
United States	McGovern Medical School at University of Texas Health Science Center Houston	Houston	Texas
United States	Indiana University Health Methodist Hospital	Indianapolis	Indiana
United States	Vanderbilt University	Nashville	Tennessee
United States	The CORE Institute / Banner University Medical Center	Phoenix	Arizona
United States	University of California San Francisco	San Francisco	California
United States	Banner - University Medical Center Tucson	Tucson	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	McMaster University, United States Department of Defense

Countries where clinical trial is conducted

United States,  Canada,  Spain, 

References & Publications (1)

O'Hara NN, Heels-Ansdell D, Bzovsky S, Dodds S, Thabane L, Bhandari M, Guyatt G, Devereaux PJ, Slobogean GP, Sprague S; PREP-IT Investigators. A pragmatic randomized trial evaluating pre-operative aqueous antiseptic skin solutions in open fractures (Aqueous-PREP): statistical analysis plan. Trials. 2022 Sep 12;23(1):772. doi: 10.1186/s13063-022-06541-0. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With a Superficial Incisional Surgical Site Infection (SSI)	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: purulent drainage from the superficial incision.; 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; 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.; diagnosis of a superficial incisional SSI by the surgeon.	Within 30 days of the patient's last planned fracture management surgery
Primary	Number of Participants With a Deep Incisional or Organ/Space Infection	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: deep incision purulent drainage; 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; 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: organ/space purulent drainage; organisms in organ/space identified by microbiologic testing; other evidence of organ/space infection on anatomical exam or imaging test	Within 90 days of the patient's last planned fracture management surgery
Secondary	Number of Participants With an Unplanned Fracture-Related Reoperation	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.	Within 12 months of the patient's last planned operation