Evaluation of the Necessity of Operative Irrigation and Debridement: Pediatric Randomized trial of type One Open Fracture (PROOF)

Eligibility

Inclusion Criteria:
  • Patients age between 3 and 14 years
  • Fracture amenable to treatment by closed reduction
  • Low energy mechanism of injury (falls from less than 10 feet, bicycle accidents)
  • Wound is less than 1 cm in length
  • Bone is not visualized through the skin

Exclusion Criteria:

  • Fracture would typically require operative reduction and fixation
  • High energy mechanism  (struck by vehicle, motor vehicle accidents, fall from height greater than 10 feet)
  • Gross contamination of the wound
  • Open injury involving the hands or feet

Contact

PI
Dr Ron El-Hawary

Description

Children with an arm fracture that breaks the skin are seen in the Emergency Department (ED). They can have the wound washed, the bone set and a cast placed in the ED, but they can also be brought to the Operating Room. In the OR a different approach is used but the goals are the same: clean the wound, realign the bone and keep it stable to allow proper healing. In the OR sometimes damaged tissue or bone is removed (called debridement) to improve the chances of good healing. There is currently no consensus or convincing data regarding whether ED treatment alone is any worse than treatment in the OR when it comes to how often these patients experience infections or how long it takes for the bone to heal.

If this study demonstrates that patients are not worse off with ED treatment alone, the benefits would be significant. Patients would be saved a trip to the OR, which includes procedure and inpatient time as well as the risks involved in anaesthesia and added possibility of infection. From an administrative perspective it would reduce the number of OR procedures required, freeing OR, surgeon and staff time for other cases. This should have a positive impact on health care costs and wait times for other cases.

Sample size= 300