Volume Reduction for Open Fracture Irrigation: A Randomized Prospective Feasibility Trial
Inova Health Care Services
Summary
The purpose of this study is to help doctors who treat open fractures understand how much fluid is required when cleaning out the wound. Participants will spend about 12 months in this study and will be asked to answer study questions about your recovery at your typical follow up clinic visits with your surgeon. After the surgeon has determined a participant's bone has healed, any remaining study visits can be conducted over the phone, email, and/or mail. Participants will not be asked to attend additional clinic visits as part of this study. Researchers will compare two different fluid volume protocols to determine if one results in better fracture and/or wound healing.
Description
This study compares the two irrigation protocols for Irrigation and Debridement (I\&D) of open fractures. Open fractures are classified using the Gustilo-Anderson classification criteria, which divides these fractures into Types I, II, and III. The study protocols being compared differ in the volume of normal sterile saline used during the I\&D procedure. Protocol A sets the volume of irrigation to be 1L normal sterile saline for Type I and Type II open fractures and 3L for Type III open fractures. Protocol B uses 3L normal saline for Type I open fractures, 6L for Type II, and 9L for Type III.…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age 18 or older * Patient diagnosed with a Type I, II, or III open fracture of the appendicular skeleton by a study surgeon * For the purposes of this study, an open fracture is a fracture associated with a soft tissue wound which may or may not be contiguous with the fracture. * Open fractures of the carpals, tarsals, metacarpals, metatarsal, and/or phalanges without the involvement of a long bone or the hindfoot will not be considered. Exclusion Criteria: * Patient is unable to understand Informed Consent and/or HIPAA Authorization Form * Patient does not speak Engli…
Interventions
- Drug0.9% Sodium Chloride
Sterile 0.9% sodium chloride irrigation administered intraoperatively for the purposes of irrigating open fracture wounds. The volume of sterile 0.9% sodium chloride solution used during irrigation is determine by the arm participants are randomized to and the open fracture classification as determined by the study surgeon in the operating room.
Location
- Inova Health SystemFalls Church, Virginia