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| Name | Class |
|---|---|
| The Physicians' Services Incorporated Foundation | OTHER |
| Orthopaedic Trauma Association | OTHER |
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The purpose of this trial is to investigate whether irrigation solution (soap vs. saline solution), or irrigation pressure (high vs. low) will decrease the rate of infection among patients with open fracture wounds.
Open fractures are an important source of morbidity and are associated with delayed union, nonunion, and infection. Preventing infection through meticulous irrigation and debridement is an important goal in management, and different lavage fluids and irrigation techniques (e.g. high or low pressure lavage) have been described for this purpose. There are, however, a limited number of randomized trials comparing irrigating solutions or irrigating technique. We compared the use of castile soap versus normal saline, as well as high versus low pressure pulsatile lavage on the rates of reoperations and complications in patients with open fracture wounds.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal saline and High pressure | Experimental | Irrigation with normal saline delivered at high pressure |
|
| Soap solution and High pressure | Experimental | Irrigation with soap solution delivered at high pressure |
|
| Normal saline and Low pressure | Experimental | Irrigation with saline solution delivered at low pressure |
|
| Soap solution and Low pressure | Experimental | Irrigation with soap solution delivered at low pressure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Type of fluid lavage solution | Procedure | Comparison of castile soap solution vs. normal saline solution. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants With Re-operations (All Subsequent Operative Procedures to Treat an Infection, a Wound Healing Problem, or a Nonunion). | one year |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants With All Operative and Non-operatively Managed Infections, Wound Healing Problems, and Nonunions. | 1 year | |
| Mean Difference in Health-related Quality of Life and Physical Function From Baseline (Pre-injury) to 12 Months Measured by the SF-12 Questionnaire (Solution). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohit Bhandari, MD, FRCSC | McMaster University | Study Chair |
| Mohit Bhandari, MD, FRCSC | McMaster University | Principal Investigator |
| Gordon Guyatt, MD, FRCSC | McMaster University | Principal Investigator |
| Kyle J Jeray, MD, FRCSC | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri Health Care | Columbia | Missouri | United States | |||
| Greenville Hospital System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11575908 | Background | Dormans JP, Fisher RC, Pill SG. Orthopaedics in the developing world: present and future concerns. J Am Acad Orthop Surg. 2001 Sep-Oct;9(5):289-96. doi: 10.5435/00124635-200109000-00002. | |
| Background | Charles Court-Brown, Margaret McQueen, Paul Tornetta III. Trauma. 1st ed. Philadelphia: Lippincott Williams and Wilkins, 2006. | ||
| 11476531 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Normal Saline and High Pressure | Irrigation with normal saline delivered at high pressure Type of fluid lavage solution: Comparison of castile soap solution vs. normal saline solution. Type of fluid lavage pressure: Comparison of low pressure vs. high pressure. |
| FG001 | Soap Solution and High Pressure | Irrigation with soap solution delivered at high pressure Type of fluid lavage solution: Comparison of castile soap solution vs. normal saline solution. Type of fluid lavage pressure: Comparison of low pressure vs. high pressure. |
| FG002 | Normal Saline and Low Pressure | Irrigation with saline solution delivered at low pressure Type of fluid lavage solution: Comparison of castile soap solution vs. normal saline solution. Type of fluid lavage pressure: Comparison of low pressure vs. high pressure. |
| FG003 | Soap Solution and Low Pressure | Irrigation with soap solution delivered at low pressure Type of fluid lavage solution: Comparison of castile soap solution vs. normal saline solution. Type of fluid lavage pressure: Comparison of low pressure vs. high pressure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Normal Saline and High Pressure | Irrigation with normal saline delivered at high pressure Type of fluid lavage solution: Comparison of castile soap solution vs. normal saline solution. Type of fluid lavage pressure: Comparison of low pressure vs. high pressure. |
| BG001 | Soap Solution and High Pressure |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Number of Participants With Re-operations (All Subsequent Operative Procedures to Treat an Infection, a Wound Healing Problem, or a Nonunion). | Posted | Count of Participants | Participants | one year |
|
12 months
Adverse Events were monitored/ assessed in such a manner that the specific Adverse Event Terms cannot be separated
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Soap, Low Pressure |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| All SAEs | Surgical and medical procedures |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| All other AEs | Surgical and medical procedures |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paula McKay, Manager | McMaster University | 9055274322 | 44131 | mckayp@mcmaster.ca |
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| ID | Term |
|---|---|
| D007239 | Infections |
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| Type of fluid lavage pressure | Procedure | Comparison of low pressure vs. high pressure. |
|
Solution and pressure were analyzed separately for this outcome. The SF-12 summary scores (PCS-12 and MCS-12) ranges from 0 to 100. Higher scores indicate that a person has better health status, while lower scores indicate poorer health status. Please note that the values reported are mean differences in scores from baseline (pre-injury) to 12 months per arm.
| 1 year |
| Mean Difference in Health-related Quality of Life and Physical Function From Baseline (Pre-injury) to 12 Months Measured by the EQ-5D Questionnaire (Solution). | Solution and pressure were analyzed separately for this outcome. The EQ-5D summary score ranges from 0 to 1. Higher scores indicate that a person has a better health-related quality of life, while lower scores indicate worse health-related quality of life. Please note that the values reported are mean differences in scores from baseline (pre-injury) to 12 months per arm. | one year |
| Mean Difference in Health-related Quality of Life and Physical Function From Baseline (Pre-injury) to 12 Months Measured by the SF-12 Questionnaire (Pressure) | Solution and pressure were analyzed separately for this outcome. The SF-12 summary scores (PCS-12 and MCS-12) ranges from 0 to 100. Higher scores indicate that a person has better health status, while lower scores indicate poorer health status. Please note that the values reported are mean differences in scores from baseline (pre-injury) to 12 months per arm. | one year |
| Mean Difference in Health-related Quality of Life and Physical Function From Baseline (Pre-injury) to 12 Months Measured by the EQ-5D Questionnaire (Pressure) | Solution and pressure were analyzed separately for this outcome. The EQ-5D summary score ranges from 0 to 1. Higher scores indicate that a person has a better health-related quality of life, while lower scores indicate worse health-related quality of life. Please note that the values reported are mean differences in scores from baseline (pre-injury) to 12 months. | one year |
| Greenville |
| South Carolina |
| United States |
| East Texas Medical Centre | Tyler | Texas | United States |
| Queen Elizabeth II Health Sciences Centre | Halifax | Nova Scotia | B3H 2A7 | Canada |
| Hamilton Health Sciences | Hamilton | Ontario | L8L 8E7 | Canada |
| Ottawa Hospital - Civic Campus | Ottawa | Ontario | Canada |
| St. Michael's Hospital | Toronto | Ontario | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | Canada |
| Sancheti Institute for Orthopaedics & Rehabilitation | Pune | Maharashtra | India |
| 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. |
| 14608171 | Background | Khatod M, Botte MJ, Hoyt DB, Meyer RS, Smith JM, Akeson WH. Outcomes in open tibia fractures: relationship between delay in treatment and infection. J Trauma. 2003 Nov;55(5):949-54. doi: 10.1097/01.TA.0000092685.80435.63. |
| 11245540 | Background | Bhandari M, Guyatt GH, Swiontkowski MF, Schemitsch EH. Treatment of open fractures of the shaft of the tibia. J Bone Joint Surg Br. 2001 Jan;83(1):62-8. doi: 10.1302/0301-620x.83b1.10986. |
| 12759640 | Background | Bhandari M, Tornetta P 3rd, Sprague S, Najibi S, Petrisor B, Griffith L, Guyatt GH. Predictors of reoperation following operative management of fractures of the tibial shaft. J Orthop Trauma. 2003 May;17(5):353-61. doi: 10.1097/00005131-200305000-00006. |
| 15005929 | Background | Spencer J, Smith A, Woods D. The effect of time delay on infection in open long-bone fractures: a 5-year prospective audit from a district general hospital. Ann R Coll Surg Engl. 2004 Mar;86(2):108-12. doi: 10.1308/003588404322827491. |
| 15995106 | Background | Anglen JO. Comparison of soap and antibiotic solutions for irrigation of lower-limb open fracture wounds. A prospective, randomized study. J Bone Joint Surg Am. 2005 Jul;87(7):1415-22. doi: 10.2106/JBJS.D.02615. |
| 10195838 | Background | Burd T, Christensen GD, Anglen JO, Gainor BJ, Conroy BP, Simpson WA. Sequential irrigation with common detergents: a promising new method for decontaminating orthopedic wounds. Am J Orthop (Belle Mead NJ). 1999 Mar;28(3):156-60. |
| 18215287 | 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. |
| 8648503 | Background | Anglen J, Apostoles PS, Christensen G, Gainor B, Lane J. Removal of surface bacteria by irrigation. J Orthop Res. 1996 Mar;14(2):251-4. doi: 10.1002/jor.1100140213. |
| 8628042 | Background | Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003. |
| Background | Brooks R, Rabin RE, de Charro F. The measurement and valuation of health status using EQ-5D: a European perspective. Kluwer Academic Publishers, 2003. |
| 11491192 | Background | Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001 Jul;33(5):337-43. doi: 10.3109/07853890109002087. |
| 1334988 | Background | Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG. CDC definitions of nosocomial surgical site infections, 1992: a modification of CDC definitions of surgical wound infections. Infect Control Hosp Epidemiol. 1992 Oct;13(10):606-8. No abstract available. |
| 19122083 | Background | Owens BD, White DW, Wenke JC. Comparison of irrigation solutions and devices in a contaminated musculoskeletal wound survival model. J Bone Joint Surg Am. 2009 Jan;91(1):92-8. doi: 10.2106/JBJS.G.01566. |
| 11263646 | Background | Bhandari M, Adili A, Schemitsch EH. The efficacy of low-pressure lavage with different irrigating solutions to remove adherent bacteria from bone. J Bone Joint Surg Am. 2001 Mar;83(3):412-9. doi: 10.2106/00004623-200103000-00014. |
| 12582808 | Background | Anglen JO, Gainor BJ, Simpson WA, Christensen G. The use of detergent irrigation for musculoskeletal wounds. Int Orthop. 2003;27(1):40-6. doi: 10.1007/s00264-002-0398-5. Epub 2002 Nov 9. |
| 7996321 | Background | Anglen JO, Apostoles S, Christensen G, Gainor B. The efficacy of various irrigation solutions in removing slime-producing Staphylococcus. J Orthop Trauma. 1994 Oct;8(5):390-6. doi: 10.1097/00005131-199410000-00004. |
| 4042875 | Background | Malten KE, den Arend JA. Irritant contact dermatitis. Traumiterative and cumulative impairment by cosmetics, climate, and other daily loads. Derm Beruf Umwelt. 1985;33(4):125-32. |
| 3608584 | Background | Strube DD, Nicoll G. The irritancy of soaps and syndets. Cutis. 1987 Jun;39(6):544-5. |
| 7829704 | Background | Simion FA, Rhein LD, Morrison BM Jr, Scala DD, Salko DM, Kligman AM, Grove GL. Self-perceived sensory responses to soap and synthetic detergent bars correlate with clinical signs of irritation. J Am Acad Dermatol. 1995 Feb;32(2 Pt 1):205-11. doi: 10.1016/0190-9622(95)90127-2. |
| 9781772 | Background | Bhandari M, Adili A, Lachowski RJ. High pressure pulsatile lavage of contaminated human tibiae: an in vitro study. J Orthop Trauma. 1998 Sep-Oct;12(7):479-84. doi: 10.1097/00005131-199809000-00009. |
| 10714777 | Background | Bhandari M, Schemitsch EH, Adili A, Lachowski RJ, Shaughnessy SG. High and low pressure pulsatile lavage of contaminated tibial fractures: an in vitro study of bacterial adherence and bone damage. J Orthop Trauma. 1999 Nov;13(8):526-33. doi: 10.1097/00005131-199911000-00002. |
| 9781768 | Background | Dirschl DR, Duff GP, Dahners LE, Edin M, Rahn BA, Miclau T. High pressure pulsatile lavage irrigation of intraarticular fractures: effects on fracture healing. J Orthop Trauma. 1998 Sep-Oct;12(7):460-3. doi: 10.1097/00005131-199809000-00005. |
| 12358372 | Background | Bhandari M, Schemitsch EH. High-pressure irrigation increases adipocyte-like cells at the expense of osteoblasts in vitro. J Bone Joint Surg Br. 2002 Sep;84(7):1054-61. doi: 10.1302/0301-620x.84b7.12532. |
| 12142830 | Background | Adili A, Bhandari M, Schemitsch EH. The biomechanical effect of high-pressure irrigation on diaphyseal fracture healing in vivo. J Orthop Trauma. 2002 Jul;16(6):413-7. doi: 10.1097/00005131-200207000-00008. |
| 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. |
| 21378581 | Derived | FLOW Investigators; Petrisor B, Sun X, Bhandari M, Guyatt G, Jeray KJ, Sprague S, Tanner S, Schemitsch E, Sancheti P, Anglen J, Tornetta P, Bosse M, Liew S, Walter S. Fluid lavage of open wounds (FLOW): a multicenter, blinded, factorial pilot trial comparing alternative irrigating solutions and pressures in patients with open fractures. J Trauma. 2011 Sep;71(3):596-606. doi: 10.1097/TA.0b013e3181f6f2e8. |
Irrigation with soap solution delivered at high pressure Type of fluid lavage solution: Comparison of castile soap solution vs. normal saline solution. Type of fluid lavage pressure: Comparison of low pressure vs. high pressure. |
| BG002 | Normal Saline and Low Pressure | Irrigation with saline solution delivered at low pressure Type of fluid lavage solution: Comparison of castile soap solution vs. normal saline solution. Type of fluid lavage pressure: Comparison of low pressure vs. high pressure. |
| BG003 | Soap Solution and Low Pressure | Irrigation with soap solution delivered at low pressure Type of fluid lavage solution: Comparison of castile soap solution vs. normal saline solution. Type of fluid lavage pressure: Comparison of low pressure vs. high pressure. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | The Number of Participants With All Operative and Non-operatively Managed Infections, Wound Healing Problems, and Nonunions. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | Mean Difference in Health-related Quality of Life and Physical Function From Baseline (Pre-injury) to 12 Months Measured by the SF-12 Questionnaire (Solution). | Solution and pressure were analyzed separately for this outcome. The SF-12 summary scores (PCS-12 and MCS-12) ranges from 0 to 100. Higher scores indicate that a person has better health status, while lower scores indicate poorer health status. Please note that the values reported are mean differences in scores from baseline (pre-injury) to 12 months per arm. | Please note that the values reported are mean differences in scores from baseline (pre-injury) to 12 months per arm. | Posted | Mean | Standard Deviation | units on a scale | 1 year |
|
|
|
| Secondary | Mean Difference in Health-related Quality of Life and Physical Function From Baseline (Pre-injury) to 12 Months Measured by the EQ-5D Questionnaire (Solution). | Solution and pressure were analyzed separately for this outcome. The EQ-5D summary score ranges from 0 to 1. Higher scores indicate that a person has a better health-related quality of life, while lower scores indicate worse health-related quality of life. Please note that the values reported are mean differences in scores from baseline (pre-injury) to 12 months per arm. | Please note that the values reported are mean differences in scores from baseline (pre-injury) to 12 months per arm. | Posted | Mean | Standard Deviation | units on a scale | one year |
|
|
|
| Secondary | Mean Difference in Health-related Quality of Life and Physical Function From Baseline (Pre-injury) to 12 Months Measured by the SF-12 Questionnaire (Pressure) | Solution and pressure were analyzed separately for this outcome. The SF-12 summary scores (PCS-12 and MCS-12) ranges from 0 to 100. Higher scores indicate that a person has better health status, while lower scores indicate poorer health status. Please note that the values reported are mean differences in scores from baseline (pre-injury) to 12 months per arm. | Please note that the values reported are mean differences in scores from baseline (pre-injury) to 12 months per arm. | Posted | Mean | Standard Deviation | units on a scale | one year |
|
|
|
| Secondary | Mean Difference in Health-related Quality of Life and Physical Function From Baseline (Pre-injury) to 12 Months Measured by the EQ-5D Questionnaire (Pressure) | Solution and pressure were analyzed separately for this outcome. The EQ-5D summary score ranges from 0 to 1. Higher scores indicate that a person has a better health-related quality of life, while lower scores indicate worse health-related quality of life. Please note that the values reported are mean differences in scores from baseline (pre-injury) to 12 months. | Please note that the values reported are mean differences in scores from baseline (pre-injury) to 12 months per arm. | Posted | Mean | Standard Deviation | units on a scale | one year |
|
|
|
| 13 |
| 27 |
| 4 |
| 27 |
| EG001 | Soap, High Pressure | 14 | 30 | 8 | 30 |
| EG002 | Saline, Low Pressure | 9 | 26 | 0 | 26 |
| EG003 | Saline, High Pressure | 11 | 27 | 6 | 27 |
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| Nonunion treated operatively or nonoperatively |
|
| Wound healing problem treated operatively or nonop |
|
| No infection, nonunion, or wound healing problems |
|