This study is currently not recruiting participants.

Supplemental Perioperative Oxygen to Reduce Surgical Site Infection After High Energy Fracture Surgery (OXYGEN Study)

Investigating Treatment for Severe Lower Leg Injuries

Not Recruiting
18 years - 80 years
Male
Phase N/A
1 Location

Brief description of study.

The purpose of this study is to determine the best treatment for severe lower leg injuries.

Detailed description of study

The study design is a prospective, double-blinded, randomized controlled trial comparing surgical site infection rates with and without Supplemental Perioperative Oxygen at the time of fracture fixation. This study design will provide the highest quality evidence to investigate our hypothesis that Supplemental Perioperative Oxygen will be effective at decreasing infection in these at-risk patients. The study population will be patients aged 18 to 80 years of age with high energy fractures to the tibial plateau, pilon or calcaneous treated operatively with plate and screw fixation.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Healthy
  • Age: 18 years - 80 years
  • Gender: Male

This study investigates treatment options for severe lower leg injuries, specifically focusing on high energy fractures of the tibial plateau, pilon, or calcaneus. These are serious injuries that occur when a large force is applied to the leg, often resulting in complex fractures. The study aims to compare infection rates after surgery with and without the use of extra oxygen during the operation.

Participants will be randomly assigned to one of two study arms. One arm will receive Supplemental Perioperative Oxygen during their surgery, while the other will not. The goal is to see if the additional oxygen helps reduce the risk of infection after the surgical procedure.

  • Who can participate: Adults between the ages of 18 and 80 with high energy fractures to the tibial plateau, pilon, or calcaneus are eligible to participate.
  • Study details: Participants will be assigned to receive either Supplemental Perioperative Oxygen or no additional oxygen during their surgery. The study will compare the infection rates between these two groups.
Updated on 19 Feb 2024. Study ID: 1404672623

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