Volume Reduction for Open Fracture Irrigation
Volume Reduction for Open Fracture Irrigation: A Randomized Prospective Feasibility Trial
Inova Health Care Services
200 participants
Mar 2, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria6
- Patient is unable to understand Informed Consent and/or HIPAA Authorization Form
- Patient does not speak English
- Patient is pregnant
- Patient is unable or (in the judgment of research personnel) unlikely to attend follow-up visits.
- Patient was previously enrolled in a study which has the same primary outcomes or may influence infection rate or bone healing
- Patient declines to participate in study
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07437339