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| ID | Type | Description | Link |
|---|---|---|---|
| W81XWH-08-1-0473 |
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| Name | Class |
|---|---|
| McMaster University | OTHER |
| United States Department of Defense | FED |
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Open fracture wounds are a constant challenge to orthopaedic surgeons, with infections a common complication. There is currently little evidence as to which is the most effective way to wash out these wounds. This study is a multi-center, prospective, randomized study. The infection rates will be compared between irrigation using high pressure versus low pressure versus gravity flow, and also saline versus a soap solution as the irrigation solution. The results from this study will help to determine the best method of washing out open fractures wounds. In this study, all open wounds will be washed out using methods commonly used by orthopaedic surgeons
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saline, gravity flow | Active Comparator |
| |
| Saline, Low Pressure | Active Comparator |
| |
| Saline, High Pressure | Active Comparator |
| |
| Soap, Gravity Flow | Active Comparator |
| |
| Soap, low pressure | Active Comparator |
| |
| Soap, high pressure | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saline Solution | Procedure | Irrigation with Saline |
|
| Measure | Description | Time Frame |
|---|---|---|
| Re-operation within 12 months post initial surgery to treat an infection, manage a wound healing problem, or promote fracture healing. | within 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient function and quality of life measured by the Short Form-12 (SF-12) and the EuroQol-5D | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyle J. Jeray, MD | Greenville Hospital System | Principal Investigator |
| Bradley Petrisor, MD | Hamilton Health Sciences Corporation | Principal Investigator |
| Mohit Bhandari, MD | McMaster University | Principal Investigator |
| Gordan Guyatt, M.D. | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univeristy of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| University of California-Irvine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33986214 | Derived | Tornetta P 3rd, Della Rocca GJ, Morshed S, Jones C, Heels-Ansdell D, Sprague S, Petrisor B, Jeray KJ, Del Fabbro G, Bzovsky S, Bhandari M; FLOW Investigators. Risk Factors Associated With Infection in Open Fractures of the Upper and Lower Extremities. J Am Acad Orthop Surg Glob Res Rev. 2020 Dec 8;4(12):e20.00188. doi: 10.5435/JAAOSGlobal-D-20-00188. | |
| 33105456 |
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| Soap solution | Procedure | Irrigation with Castile Soap Solution (80 ml per 3L bag of saline) |
|
| Gravity Flow Irrigation | Procedure | Gravity flow irrigation will be standardized across participating centers as 3L bags of normal saline (alone or with soap solution) suspended 6-8 feet above floor level using an I.V. pole. Irrigation tubing (measuring 1/4 - 3/8 inch inner diameter) will be connected to the 3L bag and secured with a stopcock (or compressive device) until ready for use. |
|
| Low Pressure Irrigation | Procedure | Irrigation with the Stryker SurgiLav System. At the low pressure setting delivers 5.9 p.s.i. pressure. The high-flow irrigator tip will be held perpendicular to and 5cm above the wound. Irrigation with the Zimmer PulsaVac. For low pressure delivery, the shower tip will be used at the low pressure setting which delivers a pressure of 5.8 p.s.i. |
|
| High Pressure | Procedure | Irrigation with the Stryker SurgiLav System. For the high pressure delivery, the multi-orifice tip will be used at the high setting which delivers a pressure of 30 p.s.i. Irrigation with the Zimmer PulsaVac System: For the high pressure delivery the shower tip will be used at the high pressure setting which delivers a pressure of 23 p.s.i. |
|
| Orange |
| California |
| 92868 |
| United States |
| University of California- San Francisco | San Francisco | California | 94110 | United States |
| Wishard Health Services, Indiana University | Indianapolis | Indiana | 46202 | United States |
| Lahey Clinic | Burlington | Massachusetts | 01805 | United States |
| Orthopaedic Associates of Michigan | Grand Rapids | Michigan | 49503 | United States |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | United States |
| University of Missouri Health Care | Columbia | Missouri | 65212 | United States |
| St. Louis University | St Louis | Missouri | 63110 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Miami Valley Hospital/Wright State University | Dayton | Ohio | 45409 | United States |
| University of Pittsburg | Pittsburgh | Pennsylvania | United States |
| Greenville Hospital System | Greenville | South Carolina | 29605 | United States |
| Brooke Army Medical Center | Fort Sam Houston | Texas | 78234 | United States |
| The Alfred | Prahran | VIC 3181 | Australia |
| Royal Columbian Hospital-New Wesminster | New Westminster | British Columbia | V3L 5P5 | Canada |
| Vancouver General Hospital | Vancouver | British Columbia | V5Z 1M9 | Canada |
| Health Sciences Winnipeg | Winnipeg | Manitoba | R3A 1R9 | Canada |
| Queen Elizabeth II Health Sciences Center | Halifax | Nova Scotia | B3H 3A7 | Canada |
| Hamilton Health Sciences | Hamilton | Ontario | L8L 2X2 | Canada |
| McMaster University | Hamilton | Ontario | Canada |
| London Health Sciences | London | Ontario | Canada |
| Ottawa Hospital- Civic | Ottawa | Ontario | K1V 4E9 | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| St. Michael's Hospital | Toronto | Ontario | M5C 1R6 | Canada |
| McGill University Health Centre | Montreal | Quebec | H3G-1A4 | Canada |
| Hospital du Sacre-Coeur de Montreal | Montreal | Quebec | H4J 1C5 | Canada |
| Hôpital de l'Enfant-Jésus | Québec | Quebec | Canada |
| Université de Sherbrooke | Sherbrooke | Quebec | Canada |
| Sancheti Institute | Prune | India |
| Ulleval University Hospital | Oslo | Norway |
| Prada C, Marcano-Fernandez FA, Schemitsch EH, Bzovsky S, Jeray K, Petrisor B, Bhandari M, Sprague S; FLOW Investigators. Timing and Management of Surgical Site Infections in Patients With Open Fracture Wounds: A Fluid Lavage of Open Wounds Cohort Secondary Analysis. J Orthop Trauma. 2021 Mar 1;35(3):128-135. doi: 10.1097/BOT.0000000000001912. |
| 30579406 | Derived | Busse JW, Heels-Ansdell D, Makosso-Kallyth S, Petrisor B, Jeray K, Tufescu T, Laflamme Y, McKay P, McCabe RE, Le Manach Y, Bhandari M; Fluid Lavage of Open Wounds Investigators. Patient coping and expectations predict recovery after major orthopaedic trauma. Br J Anaesth. 2019 Jan;122(1):51-59. doi: 10.1016/j.bja.2018.06.021. Epub 2018 Aug 6. |
| 29678204 | Derived | Sprague S, Tornetta P 3rd, Slobogean GP, O'Hara NN, McKay P, Petrisor B, Jeray KJ, Schemitsch EH, Sanders D, Bhandari M; FLOW Investigators. Are large clinical trials in orthopaedic trauma justified? BMC Musculoskelet Disord. 2018 Apr 20;19(1):124. doi: 10.1186/s12891-018-2029-3. |
| 29608532 | Derived | Shea P, O'Hara NN, Sprague SA, Bhandari M, Petrisor BA, Jeray KJ, Zhan M, Slobogean GP, Pensy RA; Fluid Lavage in Open Wounds Investigators. Wound Surface Area as a Risk Factor for Flap Complications among Patients with Open Fractures. Plast Reconstr Surg. 2018 Jul;142(1):228-236. doi: 10.1097/PRS.0000000000004418. |
| 26448371 | Derived | 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. |
| 20459600 | Derived | Flow Investigators. Fluid lavage of open wounds (FLOW): design and rationale for a large, multicenter collaborative 2 x 3 factorial trial of irrigating pressures and solutions in patients with open fractures. BMC Musculoskelet Disord. 2010 May 6;11:85. doi: 10.1186/1471-2474-11-85. |
| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D012915 | Soaps |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D003902 | Detergents |
| D013501 | Surface-Active Agents |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D006795 | Household Products |
| D013676 | Technology, Industry, and Agriculture |
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