InfectionFLOWNCT01069315
Fluid Lavage of Open Wounds (FLOW): Pilot Trial
A study testing Type of fluid lavage solution and Type of fluid lavage pressure in people with Infection and Wound Healing Problem, run by McMaster University at 9 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infection, Wound Healing Problem, Nonunion
- What is being tested?
- Type of fluid lavage solution and Type of fluid lavage pressure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 9 sitesin 3 countries
- Study dates
- Jul 2006to Jun 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- skeletally mature
- sustained an open fracture of the appendicular skeleton (type I to IIIb).
Who cannot join
- 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
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
Canada5 sites
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 2A7
Hamilton Health Sciences
Hamilton, Ontario, L8L 8E7
Ottawa Hospital - Civic Campus
Ottawa, Ontario
St. Michael's Hospital
Toronto, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario
United States3 sites
University of Missouri Health Care
Columbia, Missouri
Greenville Hospital System
Greenville, South Carolina
East Texas Medical Centre
Tyler, Texas
India1 site
Sancheti Institute for Orthopaedics & Rehabilitation
Pune, Maharashtra
About this study
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
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.
Read the detailed 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.
- Conditions
- Infection, Wound Healing Problem, Nonunion
- Being tested
- Type of fluid lavage solution, Type of fluid lavage pressure
- Keywords
- open wound, solution, pressure, randomized
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Type of fluid lavage solutionProcedure or surgery
Comparison of castile soap solution vs. normal saline solution.
Type of fluid lavage pressureProcedure or surgery
Comparison of low pressure vs. high pressure.
| Study group | Role | What they receive |
|---|---|---|
| Normal saline and High pressure | Experimental | Irrigation with normal saline delivered at high pressure Receives: Procedure: Type of fluid lavage solution; Procedure: Type of fluid lavage pressure |
| Soap solution and High pressure | Experimental | Irrigation with soap solution delivered at high pressure Receives: Procedure: Type of fluid lavage solution; Procedure: Type of fluid lavage pressure |
| Normal saline and Low pressure | Experimental | Irrigation with saline solution delivered at low pressure Receives: Procedure: Type of fluid lavage solution; Procedure: Type of fluid lavage pressure |
| Soap solution and Low pressure | Experimental | Irrigation with soap solution delivered at low pressure Receives: Procedure: Type of fluid lavage solution; Procedure: Type of fluid lavage pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants With Re-operations (All Subsequent Operative Procedures to Treat an Infection, a Wound Healing Problem, or a Nonunion).
Measured: one year
Secondary outcomes (5)
The Number of Participants With All Operative and Non-operatively Managed Infections, Wound Healing Problems, and Nonunions.
Measured: 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).
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2010 (estimated)
- Study startJul 2006
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation, Orthopaedic Trauma Association
- Responsible party
- Sponsor
- Investigators
- Mohit Bhandari, MD, FRCSC, Study chair, McMaster UniversityMohit Bhandari, MD, FRCSC, Principal investigator, McMaster UniversityGordon Guyatt, MD, FRCSC, Principal investigator, McMaster UniversityKyle J Jeray, MD, FRCSC, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01069315
- Sponsor's protocol ID
- 05-299
- Acronym
- FLOW
- Status last verified
- Mar 2019
- First submitted
- 16 Feb 2010
- Last updated
- 18 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 11575908Charles Court-Brown, Margaret McQueen, Paul Tornetta III. Trauma. 1st ed. Philadelphia: Lippincott Williams and Wilkins, 2006.
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.
PubMed 11476531Khatod 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.
PubMed 14608171Bhandari 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.
PubMed 11245540Bhandari 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.
PubMed 12759640Spencer 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.
PubMed 15005929Anglen 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.
PubMed 15995106Burd 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.
PubMed 10195838Petrisor 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.
PubMed 18215287Anglen 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.
PubMed 8648503Ware 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.
PubMed 8628042Brooks R, Rabin RE, de Charro F. The measurement and valuation of health status using EQ-5D: a European perspective. Kluwer Academic Publishers, 2003.
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.
PubMed 11491192Horan 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.
PubMed 1334988
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01069315
- Acronym / sponsor ID
- FLOW / 05-299
- Conditions
- Infection, Wound Healing Problem, Nonunion
- Keywords
- open wound, solution, pressure, randomized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation, Orthopaedic Trauma Association
- Study start
- Jul 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 17 Feb 2010 (estimated)
- Results
- Posted 18 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal saline and High pressure | Experimental | Procedure: Type of fluid lavage solution, Procedure: Type of fluid lavage pressureIrrigation with normal saline delivered at high pressure |
| Soap solution and High pressure | Experimental | Procedure: Type of fluid lavage solution, Procedure: Type of fluid lavage pressureIrrigation with soap solution delivered at high pressure |
| Normal saline and Low pressure | Experimental | Procedure: Type of fluid lavage solution, Procedure: Type of fluid lavage pressureIrrigation with saline solution delivered at low pressure |
| Soap solution and Low pressure | Experimental | Procedure: Type of fluid lavage solution, Procedure: Type of fluid lavage pressureIrrigation with soap solution delivered at low pressure |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- skeletally mature
- sustained an open fracture of the appendicular skeleton (type I to IIIb).
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Type of fluid lavage solutionComparison of castile soap solution vs. normal saline solution. | Procedure or surgery | Normal saline and High pressure, Normal saline and Low pressure, Soap solution and High pressure, Soap solution and Low pressure |
| Type of fluid lavage pressureComparison of low pressure vs. high pressure. | Procedure or surgery | Normal saline and High pressure, Normal saline and Low pressure, Soap solution and High pressure, Soap solution and Low pressure |
Primary outcome
The Number of Participants With Re-operations (All Subsequent Operative Procedures to Treat an Infection, a Wound Healing Problem, or a Nonunion).
Time frame: one year
5 secondary outcomes
The Number of Participants With All Operative and Non-operatively Managed Infections, Wound Healing Problems, and Nonunions.
Time frame: 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).
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: one year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11575908Dormans 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.
- BackgroundCharles Court-Brown, Margaret McQueen, Paul Tornetta III. Trauma. 1st ed. Philadelphia: Lippincott Williams and Wilkins, 2006.
- Background: PubMed 11476531Anglen 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: PubMed 14608171Khatod 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.
- Background: PubMed 11245540Bhandari 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.
- Background: PubMed 12759640Bhandari 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.
- Background: PubMed 15005929Spencer 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.
- Background: PubMed 15995106Anglen 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.
- Background: PubMed 10195838Burd 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.
- Background: PubMed 18215287Petrisor 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: PubMed 8648503Anglen 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.
- Background: PubMed 8628042Ware 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohit Bhandari, MD, FRCSC study chair
McMaster University
Mohit Bhandari, MD, FRCSC principal investigator
McMaster University
Gordon Guyatt, MD, FRCSC principal investigator
McMaster University
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Type of fluid lavage solution and Type of fluid lavage pressure in people with Infection and Wound Healing Problem, run by McMaster University at 9 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Canada, United States, India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number of Participants With Re-operations (All Subsequent Operative Procedures to Treat an Infection, a Wound Healing Problem, or a Nonunion). (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01069315, which also lists 29 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2019.