Comparing how much saline to use when washing open fractures
Official title: Volume Reduction for Open Fracture Irrigation: A Randomized Prospective Feasibility Trial
Run by Inova Health Care Services · NCT07437339 · Data updated 2026-11-12
This will test whether using smaller amounts of sterile saline to wash open fractures in adults works as well as using larger amounts.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Inova Health Care Services Academic / other |
| Locations | 1 site (Falls Church, Virginia) |
| Status | Recruiting |
| Started | March 2, 2026 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | April 13, 2026 |
| Trial ID | NCT07437339 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (age 18+) with Type I–III open fractures of the appendicular skeleton treated at the participating center who can consent, speak English, are not pregnant, and are likely to complete follow-up are ideal candidates.
✕Probably not a fit
Patients with fractures limited to small hand or foot bones, pregnant people, non-English speakers, those unlikely to attend follow-up, or those previously enrolled in similar infection/healing trials will not be eligible and are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, bimonthly cluster trial assigns one of two predefined saline irrigation-volume protocols to patients with Gustilo-Anderson Type I–III open fractures treated at a single center. Protocol A uses lower volumes (1L for Types I–II, 3L for Type III) while Protocol B uses higher volumes modeled on the FLOW design (3L, 6L, and 9L respectively). Treatment allocation alternates every 60 days so surgeons know the assigned volume and the trial is unblinded; outcomes include surgical site infection and fracture/wound healing over about 12 months. Follow-up is done at routine clinic visits with remote contacts allowed after radiographic healing.
Why it matters
Potential benefit: If successful, the study could show that lower irrigation volumes are safe, which might reduce operating time, fluid use, and costs without increasing infection or healing problems.
How similar studies have gone: Large prior trials informed aspects of this design—FLOW provided higher-volume comparators and PREP-IT/PREPARE supported the cluster-randomized approach—but the optimal irrigation volume for open fractures remains uncertain.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 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
Where it's running
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Inova Health System
Falls Church, Virginia, United States Recruiting
Study contacts
- Principal investigator: Abraham Goch, MD — Inova Health Care Services
- Study coordinator: Abraham Goch, MD
- Email: abraham.goch@inova.org
- Phone: (516) 209-7502
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.