Open Fracture WoundsFLOWNCT00788398
Fluid Lavage of Open Wounds
A study testing Saline Solution, Soap solution and Gravity Flow Irrigation in people with Open Fracture Wounds, run by Prisma Health-Upstate at 31 sites in 5 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 85 years
- Conditions the study is for
- Open Fracture Wounds
- What is being tested?
- Saline Solution, Soap solution and Gravity Flow Irrigation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,540 participants
- Where
- 31 sitesin 5 countries
- Study dates
- Jun 2009to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 14 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Men or women who are skeletally mature.
- Fracture of any extremity with complete radiographs.
- Open fractures (Gustilo-Anderson Types I-IIIB) (Table 2)*.
- Fracture requiring operative fixation.
- Provision of informed consent.
Who cannot join
- Open fractures with an associated vascular deficit (Gustilo-Anderson Type IIIC).
- Known allergy to detergents or castile soap ingredients.
- Previous wound infection or history of osteomyelitis in the injured extremity.
- Previous fracture with retained hardware in injured extremity that will interfere with new implant fixation.
- Surgical delay to operative wound management greater than 24 hours from hospital admission.
- Use of immunosuppressive medication within 6 months.
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- Immunological deficient disease conditions (e.g. HIV).
- Fracture of the hand (metacarpals and phalanges).
- Fracture of the toes (phalanges).
- Likely problems, in the judgment of the investigators, with maintaining follow-up. We will, for example, exclude patients with no fixed address, those who report a plan to move out of town in the next year, or intellectually challenged patients without adequate family support.
- Previous randomization in this study or a competing study.
Trial locations and contacts
31 sites in 5 countries.
31 sites in 5 countries
United States14 sites
Univeristy of Alabama at Birmingham
Birmingham, Alabama, 35294
Lahey Clinic
Burlington, Massachusetts, 01805
University of Missouri Health Care
Columbia, Missouri, 65212
Miami Valley Hospital/Wright State University
Dayton, Ohio, 45409
Duke University
Durham, North Carolina, 27710
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
Orthopaedic Associates of Michigan
Grand Rapids, Michigan, 49503
Greenville Hospital System
Greenville, South Carolina, 29605
Wishard Health Services, Indiana University
Indianapolis, Indiana, 46202
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
University of California-Irvine
Orange, California, 92868
University of Pittsburg
Pittsburgh, Pennsylvania
University of California- San Francisco
San Francisco, California, 94110
St. Louis University
St Louis, Missouri, 63110
Canada14 sites
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, B3H 3A7
Hamilton Health Sciences
Hamilton, Ontario, L8L 2X2
McMaster University
Hamilton, Ontario
London Health Sciences
London, Ontario
McGill University Health Centre
Montreal, Quebec, H3G-1A4
Hospital du Sacre-Coeur de Montreal
Montreal, Quebec, H4J 1C5
Royal Columbian Hospital-New Wesminster
New Westminster, British Columbia, V3L 5P5
Ottawa Hospital- Civic
Ottawa, Ontario, K1V 4E9
Hôpital de l'Enfant-Jésus
Québec, Quebec
Université de Sherbrooke
Sherbrooke, Quebec
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
St. Michael's Hospital
Toronto, Ontario, M5C 1R6
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
Health Sciences Winnipeg
Winnipeg, Manitoba, R3A 1R9
About this study
Official title: Fluid Lavage of Open Wounds (FLOW): A Multi-center, Blinded, Factorial Trial Comparing Alternative Irrigating Solutions and Pressures in Patients With Open Fractures
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
- Conditions
- Open Fracture Wounds
- Being tested
- Saline Solution, Soap solution, Gravity Flow Irrigation, Low Pressure Irrigation, High Pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline SolutionProcedure or surgery
Irrigation with Saline
Soap solutionProcedure or surgery
Irrigation with Castile Soap Solution (80 ml per 3L bag of saline)
Gravity Flow IrrigationProcedure or surgery
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 IrrigationProcedure or surgery
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 PressureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Saline, gravity flow | Active comparator | Not described Receives: Procedure: Saline Solution; Procedure: Gravity Flow Irrigation |
| Saline, Low Pressure | Active comparator | Not described Receives: Procedure: Saline Solution; Procedure: Low Pressure Irrigation |
| Saline, High Pressure | Active comparator | Not described Receives: Procedure: Saline Solution; Procedure: High Pressure |
| Soap, Gravity Flow | Active comparator | Not described Receives: Procedure: Soap solution; Procedure: Gravity Flow Irrigation |
| Soap, low pressure | Active comparator | Not described Receives: Procedure: Soap solution; Procedure: Low Pressure Irrigation |
| Soap, high pressure | Active comparator | Not described Receives: Procedure: Soap solution; Procedure: High Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-operation within 12 months post initial surgery to treat an infection, manage a wound healing problem, or promote fracture healing.
Measured: within 12 months
Secondary outcomes (1)
Patient function and quality of life measured by the Short Form-12 (SF-12) and the EuroQol-5D
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2008 (estimated)
- Study startJun 2009
- Primary completionJan 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Open Fracture WoundsStudies of the same condition, open and under way.
- 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
- 2,540 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University, United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Kyle J. Jeray, MD, Principal investigator, Greenville Hospital SystemBradley Petrisor, MD, Principal investigator, Hamilton Health Sciences CorporationMohit Bhandari, MD, Principal investigator, McMaster UniversityGordan Guyatt, M.D., Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00788398
- Sponsor's protocol ID
- GHS-03-08-06
- Other IDs
- W81XWH-08-1-0473
- Acronym
- FLOW
- Status last verified
- Feb 2016
- First submitted
- 7 Nov 2008
- Last updated
- 11 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33986214Prada 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.
PubMed 33105456Busse 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.
PubMed 30579406Sprague 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.
PubMed 29678204Shea 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.
PubMed 29608532FLOW 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.
PubMed 26448371Flow 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.
PubMed 20459600
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2016. 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 Trial Comparing Alternative Irrigating Solutions and Pressures in Patients With Open Fractures
- ClinicalTrials.gov ID
- NCT00788398
- Acronym / sponsor ID
- FLOW / GHS-03-08-06
- Conditions
- Open Fracture Wounds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,540 participants (actual)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Collaborators
- McMaster University, United States Department of Defense
- Study start
- Jun 2009
- Primary completion
- Jan 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 10 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Saline, gravity flow | Active comparator | Procedure: Saline Solution, Procedure: Gravity Flow Irrigation |
| Saline, Low Pressure | Active comparator | Procedure: Saline Solution, Procedure: Low Pressure Irrigation |
| Saline, High Pressure | Active comparator | Procedure: Saline Solution, Procedure: High Pressure |
| Soap, Gravity Flow | Active comparator | Procedure: Soap solution, Procedure: Gravity Flow Irrigation |
| Soap, low pressure | Active comparator | Procedure: Soap solution, Procedure: Low Pressure Irrigation |
| Soap, high pressure | Active comparator | Procedure: Soap solution, Procedure: High Pressure |
Who may qualify
- Ages
- 14 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Men or women who are skeletally mature.
- Fracture of any extremity with complete radiographs.
- Open fractures (Gustilo-Anderson Types I-IIIB) (Table 2)*.
- Fracture requiring operative fixation.
- Provision of informed consent.
Key exclusion criteria (11 listed)
- Open fractures with an associated vascular deficit (Gustilo-Anderson Type IIIC).
- Known allergy to detergents or castile soap ingredients.
- Previous wound infection or history of osteomyelitis in the injured extremity.
- Previous fracture with retained hardware in injured extremity that will interfere with new implant fixation.
- Surgical delay to operative wound management greater than 24 hours from hospital admission.
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 |
|---|---|---|
| Saline SolutionIrrigation with Saline | Procedure or surgery | Saline, High Pressure, Saline, Low Pressure, Saline, gravity flow |
| Soap solutionIrrigation with Castile Soap Solution (80 ml per 3L bag of saline) | Procedure or surgery | Soap, Gravity Flow, Soap, high pressure, Soap, low pressure |
| Gravity Flow IrrigationGravity 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. | Procedure or surgery | Saline, gravity flow, Soap, Gravity Flow |
| Low Pressure IrrigationIrrigation 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. | Procedure or surgery | Saline, Low Pressure, Soap, low pressure |
| High PressureIrrigation 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. | Procedure or surgery | Saline, High Pressure, Soap, high pressure |
Primary outcome
Re-operation within 12 months post initial surgery to treat an infection, manage a wound healing problem, or promote fracture healing.
Time frame: within 12 months
1 secondary outcome
Patient function and quality of life measured by the Short Form-12 (SF-12) and the EuroQol-5D
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2016.
- Derived from this study: PubMed 33986214Tornetta 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.
- Derived from this study: PubMed 33105456Prada 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.
- Derived from this study: PubMed 30579406Busse 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.
- Derived from this study: PubMed 29678204Sprague 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.
- Derived from this study: PubMed 29608532Shea 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.
- Derived from this study: PubMed 26448371FLOW 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.
- Derived from this study: PubMed 20459600Flow 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.
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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.
Kyle J. Jeray, MD principal investigator
Greenville Hospital System
Bradley Petrisor, MD principal investigator
Hamilton Health Sciences Corporation
Mohit Bhandari, MD principal investigator
McMaster University
31 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saline Solution, Soap solution and Gravity Flow Irrigation in people with Open Fracture Wounds, run by Prisma Health-Upstate at 31 sites in 5 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 5 inclusion and 11 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 11 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Canada, Australia, India, Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Re-operation within 12 months post initial surgery to treat an infection, manage a wound healing problem, or promote fracture healing. (time frame: within 12 months). 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 NCT00788398, which also lists 7 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 11 Feb 2016.