Volume Reduction for Open Fracture Irrigation

Volume Reduction for Open Fracture Irrigation: A Randomized Prospective Feasibility Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Open Fracture
• Intervention / Treatment: Drug: 0.9% Sodium Chloride

Detailed Description

This study compares the two irrigation protocols for Irrigation and Debridement (I&D) of open fractures. Open fractures are classified using the Gustilo-Anderson classification criteria, which divides these fractures into Types I, II, and III. The study protocols being compared differ in the volume of normal sterile saline used during the I&D procedure. Protocol A sets the volume of irrigation to be 1L normal sterile saline for Type I and Type II open fractures and 3L for Type III open fractures. Protocol B uses 3L normal saline for Type I open fractures, 6L for Type II, and 9L for Type III. Irrigation volumes for Protocol A are based on current practice by orthopedic trauma surgeons at Inova. Volumes in Protocol B are based on the FLOW trial study design.

Hypothesis: Decreased irrigation volumes (Protocol A) during surgical I&D will be non-inferior to high irrigation volumes (Protocol B) with respect to the development of surgical site infection.

Study Design: This is a bimonthly cluster randomized trial in which the study. When enrollment begins, the first two-month (60-day) period will be randomly assigned to either Protocol A or B. Thereafter, the study treatment in effect allocation will alternate every two months (60 days). Since investigators will need this information to conduct the study treatment they cannot be blinded to treatment assignments.

This study design is based on the PREP-IT and PREPARE trials, which were national, multicenter RCTs that compared post-surgical infection rates after using different skin sterilization solutions to prepare surgical sites of open and closed fractures.

Patients will receive the protocol in effect at the time they consent to participate in the study, prior to their I&D, unless otherwise clinically indicated by their study surgeon while in the operating room (OR). All open fracture patients will be screened for participation in the study during their initial evaluation and admission to the hospital, based on inclusion and exclusion criteria detailed in the study protocol. A member of the study team will discuss the study with patients meeting the appropriate criteria prior to their first I&D. These patients will either be consented/enrolled or will be screen failed due to lack of consent.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Abraham Goch, MD; Phone Number: (516) 209-7502; Email: abraham.goch@inova.org
• Study Contact Backup: Name: Greg Gaski, MD; Phone Number: (786) 473-8895; Email: greg.gaski@inova.org

Study Locations

• United States
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Recruiting
      • Inova Health System
      • Contact: Greg Gaski, MD; Phone Number: (786) 473-8895; Email: greg.gaski@inova.org
      • Contact: Abraham Goch, MD; Phone Number: 516-209-7502; Email: abraham.goch@inova.org
      • Principal Investigator: Abraham Goch, MD
      • Sub-Investigator: Greg Gaski, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	Drug: 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.; Other Names: Saline; Normal Saline; Normal Sterile Saline; Sterline Saline
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).	Drug: 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.; Other Names: Saline; Normal Saline; Normal Sterile Saline; Sterline Saline

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Inova Health Care Services
• Collaborators: Society of Military Orthopedic Surgeons
• Investigators: Principal Investigator: Abraham Goch, MD, Inova Health Care Services

Publications and helpful links

General Publications

• Anglen JO. Wound irrigation in musculoskeletal injury. J Am Acad Orthop Surg. 2001 Jul-Aug;9(4):219-26. doi: 10.5435/00124635-200107000-00001.
• Garrett WE Jr, Swiontkowski MF, Weinstein JN, Callaghan J, Rosier RN, Berry DJ, Harrast J, Derosa GP. American Board of Orthopaedic Surgery Practice of the Orthopaedic Surgeon: Part-II, certification examination case mix. J Bone Joint Surg Am. 2006 Mar;88(3):660-7. doi: 10.2106/JBJS.E.01208. No abstract available.
• Barnes S, Spencer M, Graham D, Johnson HB. Surgical wound irrigation: a call for evidence-based standardization of practice. Am J Infect Control. 2014 May;42(5):525-9
• Crowley DJ, Kanakaris NK, Giannoudis PV. Irrigation of the wounds in open fractures. J Bone Joint Surg Br. 2007 May;89(5):580-5.
• Howard M, Court-Brown CM. Epidemiology and management of open fractures of the lower limb. Br J Hosp Med. 1997 Jun 4-17;57(11):582-7
• Peterson L.W. Prophylaxis of wound infection: studies with particular reference to soaps and irrigation. Arch Surg. 1945;50(4):177-183
• Zalavras CG, Marcus RE, Levin S, Patzakis MJ. Management of Open Fractures and Subsequent Complications. J Bone Joint Surg Am. 2007 Apr;89(4):884-895.
• Cross WW, Swiontkowski MF. Treatment principles in the management of open fractures. Indian J Orthop. 2008 Oct-Dec;42(4):377-86
• FLOW Investigators; Bhandari M, Jeray KJ, Petrisor BA, Devereaux PJ, Heels-Ansdell D, Schemitsch EH, Anglen J, Della Rocca GJ, Jones C, Kreder H, Liew S, McKay P, Papp S, Sancheti P, Sprague S, Stone TB, Sun X, Tanner SL, Tornetta P 3rd, Tufescu T, Walter S, Guyatt GH. A Trial of Wound Irrigation in the Initial Management of Open Fracture Wounds. N Engl J Med. 2015 Dec 31;373(27):2629-41
• Petrisor B., Jeray K., Schemitsch E. Fluid lavage in patients with open fracture wounds (FLOW): an international survey of 984 surgeons. BMC Muscoskel Disord. 2008;9(1):7.
• Wilkins J., Patzakis M. Choice and duration of antibiotics in open fractures. Orthop Clin N Am. 1991;22(3):433-437
• Nicks BA, Ayello EA, Woo K, Nitzki-George D, Sibbald RG. Acute wound management: revisiting the approach to assessment, irrigation, and closure considerations. Int J Emerg Med. 2010 Aug;3:399-407
• Kim PH, Leopold SS. Gustilo-Anderson Classification. Clin Orthop Relat Res. 2012 Nov;470(11):3270-4.
• Weiss EA, Oldham G, Lin M, Foster T, Quinn JV. Water is a safe and effective alternative to sterile normal saline for wound irrigation prior to suturing: a prospective, double-blind, randomised, controlled clinical trial. BMJ Open. 2013 Jan;3(1).
• Marcario A. What does one minute of operating room time cost? J Clin Anesth. 2010 Jun;22(4):223-6.
• Park KW, Dickerson C. Can efficient supply management in the operating room save millions? Curr Opin Anaesthesiol. 2009;22:242-48.
• Shipper R. A Study of Time-Dependent Operating Room Fees and How to Save $100,000 by Using Time-Saving Products. Am J of Cosmetic Surg. 2005;22(1).
• Svoboda SJ, Bice TG, Gooden HA, Brooks DE, Thomas DB, Wenke JC. Comparison of bulb syringe and pulsed lavage irrigation with use of a bioluminescent musculoskeletal wound model. J Bone Joint Surg Am. 2006 Oct;88(10):2167-74.
• Owens BD, Wenke JC. Early wound irrigation improves the ability to remove bacteria. J Bone Joint Surg Am. 2007 Aug;89(8):1723-6.
• Savitsky E, Eastridge B. Combat Casualty Care: Lessons Learned from OEF and OIF.The Office of the Surgeon General. Department of the Army. 2012. 483-4.
• Luedtke-Hoffmann KA, Schafer DS. Pulsed lavage in wound cleansing. Phys Ther. 2000 Mar;80(3):292-300.
• Rodeheaver GT, Pettry D, Thacker JG, Edgerton MT, Edlich RF. Wound cleansing by high pressure irrigation. Surg Gynecol Obstet. 1975 Sep;141(3):357-62.
• Okike K, Bhattacharyya T. Trends in the management of open fractures. A critical analysis. J Bone Joint Surg Am. 2006 Dec;88(12):2739-48.
• Gustilo RB, Anderson JT. Prevention of infection in the treatment of one thousand and twenty-five open fractures of long bones: retrospective and prospective analyses. J Bone Joint Surg Am. 1976;58:453-8.
• Lee J. Efficacy of cultures in the management of open fractures. Clin Orthop Relat Res. 1997;339:71-5.

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: February 20, 2026
• First Submitted That Met QC Criteria: February 20, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Fractures, Open; Pharmaceutical Preparations; Inorganic Chemicals; Chlorine Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Sodium Compounds; Chlorides; Hydrochloric Acid; Saline Solution; Sodium Chloride
• Other Study ID Numbers: INOVA-2025-149

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a pilot study taking place at one hospital system. All data analysis is planned to take place in-house and there are currently no established data use agreements for the information to be collected.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No