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Completed

NCT Number: NCT03385304

Pre-operative Aqueous Antiseptic Skin Solutions in Open Fractures

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.

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Key information

Conditions

Surgical Site Infection Fractures, Bone Fractures, Open Infections Open Appendicular Fracture Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Unplanned Fracture-Related Reoperation Wound Infection Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hamilton Health Sciences, Hamilton, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

The inclusion criteria are:

  • Patients 18 years of age or older.
  • Open fracture of the appendicular skeleton.
  • Received or will receive definitive fracture treatment with a surgical implant(s) (e.g., internal fixation, external fixation, joint prosthesis, etc.).
  • Open fracture wound management that includes formal surgical debridement within 72 hours of their injury.
  • Will have all planned fracture care surgeries performed by a participating surgeon or delegate.
  • Informed consent obtained.
  • Patient enrolled within 3 weeks of their fracture.

The exclusion criteria are:

  • Patients that did not or will not receive the allocated pre-operative surgical preparation solution due to a medical contraindication.
  • Received previous surgical debridement or management of their open fracture at a non-participating hospital or clinic.
  • Open fracture managed outside of the participating orthopaedic service (e.g., hand fracture managed by plastic surgeon).
  • Chronic or acute infection at or near the fracture site at the time of initial fracture surgery.
  • Burns at the fracture site.
  • Incarceration.
  • Expected injury survival of less than 90 days.
  • Terminal illness with expected survival less than 90 days.
  • Previous enrollment in a PREP-IT trial.
  • Currently enrolled in a study that does not permit co-enrollment.
  • Unable to obtain informed consent due to language barriers.
  • Likely problems, in the judgment of study personnel, with maintaining follow-up with the patient.
  • Excluded due to sampling strategy.

Treatment and study plan

10% povidone-iodine (1% free iodine) in purified water

Drug

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

Drug

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.

Primary outcomes

  1. Number of Participants With a Superficial Incisional Surgical Site Infection (SSI)

    Time frame: 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:

    • 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.

  2. Number of Participants With a Deep Incisional or Organ/Space Infection

    Time frame: 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:

    • 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

Secondary outcomes

  1. Number of Participants With an Unplanned Fracture-Related Reoperation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

  • McMaster University
  • United States Department of Defense

Registry information

Official study title

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

Acronym: Aqueous-PREP

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Dec 28, 2017
Registry last updated
Mar 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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