Prevention of Postsurgery Infection

Condition: Postoperative Wound Infection After Fracture Surgery

Eligibility

Key Inclusion Criteria

  • All "high energy" tibial plateau fractures treated operatively with plate and screw fixation
  • All "high energy" pilon (tibial plafond) fractures treated operatively with plate and screw fixation
  • All "high energy" calcaneus fractures treated operatively with plate and screw fixation in a staged fashion
  • 18-80 years old

Key Exclusion Criteria

  • Tibial plateau, pilon, or calcaneus already infected at time of study enrollment
  • Type IIIB or IIIC open fractures
  • Patient with massive myonecrosis from ipsilateral leg compartment syndrome

Full Study Name

Supplemental Perioperative Oxygen to Reduce Surgical Site Infection After High-Energy Fracture Surgery (IRB no. 45760)

Summary

This study focuses on individuals who have a severe injury of the lower leg, foot or ankle. The study is designed to test the investigational use of a higher mix of oxygen and determine the best treatment for severe lower leg injuries. Previous research with patients who have had belly surgery has shown that by giving a patient more oxygen during surgery, they have a smaller risk for infection later. Researchers would like to determine whether this works in a similar manner for patients who have surgery for a broken bone. Researchers will compare the proportion of surgical wound infections in patients who received more oxygen during the surgery to the standard treatment in order to determine which is more effective. 

Research participants in Group 1 will receive a higher mix of oxygen during surgery for up to two hours in the recovery room. Group 2 will receive a standard mix of oxygen during surgery for the same amount of time in the recovery room.

Phase
Phase III


Principal Investigator

Charles Moon, MD

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