Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion
Saam Morshed

Description

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.

Official Title

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

Keywords

Surgical Site Infection Unplanned Fracture-Related Reoperation Open Appendicular Fracture Open Fracture Povidone-iodine Chlorhexidine gluconate Peri-operative Preparation Solutions Fractures, Bone Surgical Wound Infection Fractures, Open Pharmaceutical Solutions Chlorhexidine Iodine Cadexomer iodine Anti-Infective Agents, Local Povidone 10% povidone-iodine (1% free iodine) in purified water 4% chlorhexidine gluconate (CHG) in purified water

Eligibility

For people ages 18 years and up

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. Currently enrolled in a study that does not permit co-enrollment.
  10. . Unable to obtain informed consent due to language barriers.
  11. . Problems, in the judgment of study personnel, with maintaining follow-up with the patient.
  12. . Previously enrolled in the Aqueous-PREP trial.

Locations

  • University of California San Fransisco
    San Francisco California 94143 United States
  • The CORE Institute / Banner University Medical Center
    Phoenix Arizona 85006 United States

Lead Scientist

  • Saam Morshed
    Dr. Morshed completed his undergraduate education at Harvard University. He completed his medical education and residency in orthopaedic surgery at the University of California, San Francisco.

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
University of Maryland
ID
NCT03385304
Phase
Phase 4
Study Type
Interventional
Last Updated