Volume Reduction for Open Fracture Irrigation

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.

Timeline

Start

2026-03-02

Primary completion

2027-12-31

Completion

2027-12-31

Publications

• Background 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.
• Background 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.
• Background 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. doi: 10.1016/j.ajic.2014.01.012.
• 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. doi: 10.1302/0301-620X.89B5.19286.
• 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 LS, Patzakis MJ. Management of open fractures and subsequent complications. J Bone Joint Surg Am. 2007 Apr;89(4):884-95. doi: 10.2106/00004623-200704000-00027. No abstract available.
• Background Cross WW 3rd, Swiontkowski MF. Treatment principles in the management of open fractures. Indian J Orthop. 2008 Oct;42(4):377-86. doi: 10.4103/0019-5413.43373.
• 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. doi: 10.1056/NEJMoa1508502. Epub 2015 Oct 8.
• Background Petrisor B, Jeray K, Schemitsch E, Hanson B, Sprague S, Sanders D, Bhandari M; FLOW Investigators. Fluid lavage in patients with open fracture wounds (FLOW): an international survey of 984 surgeons. BMC Musculoskelet Disord. 2008 Jan 23;9:7. doi: 10.1186/1471-2474-9-7.
• Background Wilkins J, Patzakis M. Choice and duration of antibiotics in open fractures. Orthop Clin North Am. 1991 Jul;22(3):433-7.
• 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 27;3(4):399-407. doi: 10.1007/s12245-010-0217-5.
• Background Kim PH, Leopold SS. In brief: Gustilo-Anderson classification. [corrected]. Clin Orthop Relat Res. 2012 Nov;470(11):3270-4. doi: 10.1007/s11999-012-2376-6. Epub 2012 May 9. No abstract available.
• 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 16;3(1):e001504. doi: 10.1136/bmjopen-2012-001504.
• Background Macario A. What does one minute of operating room time cost? J Clin Anesth. 2010 Jun;22(4):233-6. doi: 10.1016/j.jclinane.2010.02.003. No abstract available.
• Background Park KW, Dickerson C. Can efficient supply management in the operating room save millions? Curr Opin Anaesthesiol. 2009 Apr;22(2):242-8. doi: 10.1097/ACO.0b013e32832798ef.
• 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. doi: 10.2106/JBJS.E.00248.
• 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. doi: 10.2106/JBJS.F.01210.
• 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. No abstract available.
• 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. doi: 10.2106/JBJS.F.00146. No abstract available.
• 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 Jun;58(4):453-8.
• Background Lee J. Efficacy of cultures in the management of open fractures. Clin Orthop Relat Res. 1997 Jun;(339):71-5. doi: 10.1097/00003086-199706000-00010.

Drugs

Indications

No indication recorded.