Comparing how much saline to use when washing open fractures
Volume Reduction for Open Fracture Irrigation: A Randomized Prospective Feasibility Trial
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 |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Inova Health Care Services Academic / other |
| Locations | 1 site (Falls Church, Virginia) |
| Trial ID | NCT07437339 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Falls Church, Virginia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.