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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00788398




Registration number
NCT00788398
Ethics application status
Date submitted
7/11/2008
Date registered
10/11/2008
Date last updated
11/02/2016

Titles & IDs
Public title
Fluid Lavage of Open Wounds
Scientific title
Fluid Lavage of Open Wounds (FLOW): A Multi-center, Blinded, Factorial Trial Comparing Alternative Irrigating Solutions and Pressures in Patients With Open Fractures
Secondary ID [1] 0 0
W81XWH-08-1-0473
Secondary ID [2] 0 0
GHS-03-08-06
Universal Trial Number (UTN)
Trial acronym
FLOW
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Open Fracture Wounds 0 0
Condition category
Condition code
Skin 0 0 0 0
Other skin conditions
Injuries and Accidents 0 0 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Saline Solution
Treatment: Surgery - Soap solution
Treatment: Surgery - Gravity Flow Irrigation
Treatment: Surgery - Low Pressure Irrigation
Treatment: Surgery - High Pressure

Active Comparator: 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 -


Treatment: Surgery: Saline Solution
Irrigation with Saline

Treatment: Surgery: Soap solution
Irrigation with Castile Soap Solution (80 ml per 3L bag of saline)

Treatment: Surgery: Gravity Flow Irrigation
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.

Treatment: Surgery: Low Pressure Irrigation
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.

Treatment: Surgery: High Pressure
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.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Re-operation within 12 months post initial surgery to treat an infection, manage a wound healing problem, or promote fracture healing.
Timepoint [1] 0 0
within 12 months
Secondary outcome [1] 0 0
Patient function and quality of life measured by the Short Form-12 (SF-12) and the EuroQol-5D
Timepoint [1] 0 0
12 months

Eligibility
Key inclusion criteria
1. Men or women who are skeletally mature.

2. Fracture of any extremity with complete radiographs.

3. Open fractures (Gustilo-Anderson Types I-IIIB) (Table 2)*.

4. Fracture requiring operative fixation.

5. Provision of informed consent.
Minimum age
14 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Open fractures with an associated vascular deficit (Gustilo-Anderson Type IIIC).

2. Known allergy to detergents or castile soap ingredients.

3. Previous wound infection or history of osteomyelitis in the injured extremity.

4. Previous fracture with retained hardware in injured extremity that will interfere with
new implant fixation.

5. Surgical delay to operative wound management greater than 24 hours from hospital
admission.

6. Use of immunosuppressive medication within 6 months.

7. Immunological deficient disease conditions (e.g. HIV).

8. Fracture of the hand (metacarpals and phalanges).

9. Fracture of the toes (phalanges).

10. 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.

11. Previous randomization in this study or a competing study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2015
Sample size
Target
Accrual to date
Final
2540
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Alfred - Prahran
Recruitment postcode(s) [1] 0 0
VIC 3181 - Prahran
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
South Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
Canada
State/province [13] 0 0
British Columbia
Country [14] 0 0
Canada
State/province [14] 0 0
Manitoba
Country [15] 0 0
Canada
State/province [15] 0 0
Nova Scotia
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Canada
State/province [17] 0 0
Quebec
Country [18] 0 0
India
State/province [18] 0 0
Prune
Country [19] 0 0
Norway
State/province [19] 0 0
Oslo

Funding & Sponsors
Primary sponsor type
Other
Name
Prisma Health-Upstate
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
McMaster University
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
United States Department of Defense
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief 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. 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
Trial website
https://clinicaltrials.gov/ct2/show/NCT00788398
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kyle J. Jeray, MD
Address 0 0
Greenville Hospital System
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00788398