Fluid Lavage of Open Wounds (FLOW): Pilot Trial

Infection Clinical Trial

— FLOW  

Official title:

Fluid Lavage of Open Wounds (FLOW): A Multi-Center, Blinded, Factorial Pilot Trial Comparing Alternative Irrigating Solutions and Pressures in Patients With Open Fractures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01069315
• Other study ID #: 05-299
• Status: Completed
• Phase: N/A
• Start date: July 2006
• Est. completion date: June 2008

Study information

• Verified date: March 2019
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• skeletally mature

• sustained an open fracture of the appendicular skeleton (type I to IIIb).

Exclusion Criteria:

• vascular deficit

• [any] allergy to detergents or castile soap

• previous wound infection or osteomyelitis

• previous fracture with retained hardware in the injured extremity

• operative management more than 24 hours after injury

• use of immunosuppressive medication within six months

• immunological deficiency or disease conditions

• fractures of the hands (distal to the carpus) or toes

Related Conditions & MeSH terms

• Infection
• Nonunion
• Wound Healing Problem
• Wounds and Injuries

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Canada	Queen Elizabeth II Health Sciences Centre	Halifax	Nova Scotia
Canada	Hamilton Health Sciences	Hamilton	Ontario
Canada	Ottawa Hospital - Civic Campus	Ottawa	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
India	Sancheti Institute for Orthopaedics & Rehabilitation	Pune	Maharashtra
United States	University of Missouri Health Care	Columbia	Missouri
United States	Greenville Hospital System	Greenville	South Carolina
United States	East Texas Medical Centre	Tyler	Texas

Sponsors (3)

Lead Sponsor	Collaborator
McMaster University	Orthopaedic Trauma Association, The Physicians' Services Incorporated Foundation

Countries where clinical trial is conducted

United States,  Canada,  India, 

References & Publications (27)

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. — View Citation

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. — View Citation

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. — View Citation

Anglen JO, Gainor BJ, Simpson WA, Christensen G. The use of detergent irrigation for musculoskeletal wounds. Int Orthop. 2003;27(1):40-6. Epub 2002 Nov 9. — View Citation

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. — View Citation

Anglen JO. Wound irrigation in musculoskeletal injury. J Am Acad Orthop Surg. 2001 Jul-Aug;9(4):219-26. Review. — View Citation

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. — View Citation

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-A(3):412-9. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Brooks R, Rabin RE, de Charro F. The measurement and valuation of health status using EQ-5D: a European perspective. Kluwer Academic Publishers, 2003.

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. — View Citation

Charles Court-Brown, Margaret McQueen, Paul Tornetta III. Trauma. 1st ed. Philadelphia: Lippincott Williams and Wilkins, 2006.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001 Jul;33(5):337-43. Review. — View Citation

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. — View Citation

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. — View Citation

Strube DD, Nicoll G. The irritancy of soaps and syndets. Cutis. 1987 Jun;39(6):544-5. — View Citation

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. — View Citation

* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Participants With Re-operations (All Subsequent Operative Procedures to Treat an Infection, a Wound Healing Problem, or a Nonunion).		one year
Secondary	The Number of Participants With All Operative and Non-operatively Managed Infections, Wound Healing Problems, and Nonunions.		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.	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.	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.	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.	one year