Volume Reduction for Open Fracture Irrigation Study

This study aims to help doctors understand the best amount of sterile 0.9% sodium chloride (saltwater solution) to use when cleaning open fracture wounds during surgery. You may be able to join if you are 18 or older and have an open fracture (a broken bone with a skin wound) in your arms or legs. Researchers will compare two different amounts of saltwater solution to see if one leads to better healing and fewer surgical site infections (infections at the surgery site). The main goal is to see if using less saltwater solution is just as good as using more to prevent infections. You would be in the study for about 12 months, and your recovery will be checked during your regular follow-up visits with your surgeon. Some later visits can even be done by phone, email, or mail.

Study design
This is a cluster randomized trial with 200 planned participants, comparing two different irrigation protocols. The study alternates between the two protocols every two months.
What's involved
You will be in the study for about 12 months, with your recovery checked during typical follow-up clinic visits. Later visits may be conducted by phone, email, or mail.
Compensation
Not stated in the trial record.
Follow-up
Your surgical site infection will be measured at 90 days after your first irrigation and debridement procedure.

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NCT07437339

Volume Reduction for Open Fracture Irrigation

Recruiting
PHASE4Ages 18+InterventionalTreatment
Inova Health Care Services
~200 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:0.9% Sodium Chloride

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Surgical Site Infection (SSI) following irrigation and debridement of open fractures.
Measured over 90 days after first irrigation and debridement conducted in the operating room
Open Fracture
1 sites across 1 states
Virginia1
  • Abraham Goch, MD · PRINCIPAL_INVESTIGATOR · Inova Health Care Services

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Eligibility criteria

Inclusion

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

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
  • Incidence of Surgical Site Infection (SSI) following irrigation and debridement of open fractures.90 days after first irrigation and debridement conducted in the operating room

    Surgical site infection within 90 days of I\&D, per CDC definition. The site of interest for this study is the wound created by the fracture mechanism and the debridement thereof. It does not refer to incisions required solely for fixation.