Pre-operative Aqueous Antiseptic Skin Solutions in Open Fractures (NCT03385304) | Clinical Trial Compass
CompletedPhase 4
Pre-operative Aqueous Antiseptic Skin Solutions in Open Fractures
United States1,638 participantsStarted 2018-04-08
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Number of Participants With a Superficial Incisional Surgical Site Infection (SSI)
Timeframe: Within 30 days of the patient's last planned fracture management surgery
2
Number of Participants With a Deep Incisional or Organ/Space Infection
Timeframe: Within 90 days of the patient's last planned fracture management surgery