NCT07437339

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
18mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Mar 2026Dec 2027

First Submitted

Initial submission to the registry

February 20, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

March 2, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1.8 years

First QC Date

February 20, 2026

Last Update Submit

April 8, 2026

Conditions

Open Fracture

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Irrigation Protocol A

ACTIVE COMPARATOR

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

Irrigation Protocol B

ACTIVE COMPARATOR

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

Interventions

0.9% Sodium ChlorideDRUG

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.

Also known as: Normal Sterile Saline, Sterline Saline, Normal Saline, Saline
Irrigation Protocol AIrrigation Protocol B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inova Health System

Falls Church, Virginia, 22042, United States

RECRUITING

Related Publications (25)

  • 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.

    PMID: 16510834BACKGROUND

  • 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.

    PMID: 11476531BACKGROUND

  • 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

    BACKGROUND

  • Crowley DJ, Kanakaris NK, Giannoudis PV. Irrigation of the wounds in open fractures. J Bone Joint Surg Br. 2007 May;89(5):580-5.

    BACKGROUND

  • 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

    BACKGROUND

  • Peterson L.W. Prophylaxis of wound infection: studies with particular reference to soaps and irrigation. Arch Surg. 1945;50(4):177-183

    BACKGROUND

  • 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.

    BACKGROUND

  • Cross WW, Swiontkowski MF. Treatment principles in the management of open fractures. Indian J Orthop. 2008 Oct-Dec;42(4):377-86

    BACKGROUND

  • 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

    BACKGROUND

  • 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.

    BACKGROUND

  • Wilkins J., Patzakis M. Choice and duration of antibiotics in open fractures. Orthop Clin N Am. 1991;22(3):433-437

    BACKGROUND

  • 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

    BACKGROUND

  • Kim PH, Leopold SS. Gustilo-Anderson Classification. Clin Orthop Relat Res. 2012 Nov;470(11):3270-4.

    BACKGROUND

  • 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).

    BACKGROUND

  • Marcario A. What does one minute of operating room time cost? J Clin Anesth. 2010 Jun;22(4):223-6.

    BACKGROUND

  • Park KW, Dickerson C. Can efficient supply management in the operating room save millions? Curr Opin Anaesthesiol. 2009;22:242-48.

    BACKGROUND

  • 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).

    BACKGROUND

  • 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.

    BACKGROUND

  • Owens BD, Wenke JC. Early wound irrigation improves the ability to remove bacteria. J Bone Joint Surg Am. 2007 Aug;89(8):1723-6.

    BACKGROUND

  • 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.

    BACKGROUND

  • Luedtke-Hoffmann KA, Schafer DS. Pulsed lavage in wound cleansing. Phys Ther. 2000 Mar;80(3):292-300.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • Lee J. Efficacy of cultures in the management of open fractures. Clin Orthop Relat Res. 1997;339:71-5.

    BACKGROUND

MeSH Terms

Conditions

Fractures, Open

Interventions

Sodium ChlorideSaline Solution

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Abraham Goch, MD

    Inova Health Care Services

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Abraham Goch, MD

CONTACT

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

Greg Gaski, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: During Irrigation and Debridement of an open fracture, patients will receive an irrigation volume dictated by either Protocol A or B as shown in the figure above. 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. This study will follow bimonthly cluster randomization design in which a cluster is defined as admitted open fracture patients requiring I\&D in the OR within a two-month period. The first two-month period will be randomly assigned to either Protocol A or B and treatment allocation will alternate from that point. Since investigators will need this information to conduct the study treatment they cannot be blinded to treatment assignments.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2026

First Posted

February 27, 2026

Study Start

March 2, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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.

Locations

US(1)