Recruiting

Fluid Volume Protocols

Sponsor:

Inova Health Care Services

Code:

NCT07437339

Conditions

Open Fracture

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

0.9% Sodium Chloride

Study Details

Brief 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.

Conditions

Open Fracture

Study ID

NCT07437339

Start date

Mar 2, 2026

Status verified date

Apr, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Irrigation Protocol A

Protocol A sets the volume of irrigation as 1 liter normal sterile saline (0.9% sodium chloride) for Type I and Type II open fractures and 3 liters for Type III open fractures. Open fracture type is determined by the study surgeon in the operating room (OR).

active comparator: Irrigation Protocol B

Protocol B sets irrigation volumes as 3 liters normal sterile saline (0.9% sodium chloride) for Type I open fractures, 6 liters for Type II, and 9 liters for Type III. The fracture type is determined by the study surgeon in the operating room (OR).

Interventions

0.9% 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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Abraham Goch, MD

(516) 209-7502abraham.goch@inova.org

Greg Gaski, MD

(786) 473-8895greg.gaski@inova.org

Locations

Inova Health System

Recruiting

Falls Church, Virginia, United States, 22042

Contacts

Abraham Goch, MD

516-209-7502abraham.goch@inova.org

Greg Gaski, MD

(786) 473-8895greg.gaski@inova.org

Principal Investigator:

Abraham Goch, MD

More Information

Sponsor

Inova Health Care Services

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Inova Health Care Services on 2026-04-13.