Volume Reduction for Open Fracture Irrigation

Conditions

• Open Fracture

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 0.9% Sodium Chloride — DRUG
  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.

Study Details

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.

Key Dates

Start date

Mar 2, 2026

Status verified

Apr 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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).

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

• Abraham Goch, MD
  (516) 209-7502
  [email protected]
• Greg Gaski, MD
  (786) 473-8895
  [email protected]

Locations (1)

Find similar trials in Falls Church, VA

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