Fluid Lavage of Open Wounds (FLOW)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
McMaster University
Information provided by (Responsible Party):
Greenville Hospital System University Medical Center
ClinicalTrials.gov Identifier:
NCT00788398
First received: November 7, 2008
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention
Open Fracture Wounds
Procedure: Saline Solution
Procedure: Soap solution
Procedure: Gravity Flow Irrigation
Procedure: Low Pressure Irrigation
Procedure: High Pressure

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Greenville Hospital System University Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient function and quality of life measured by the Short Form-12 (SF-12) and the EuroQol-5D [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 2280
Study Start Date: June 2009
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Saline, gravity flow Procedure: Saline Solution
Irrigation with Saline
Procedure: 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.
Active Comparator: Saline, Low Pressure Procedure: Saline Solution
Irrigation with Saline
Procedure: 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.

Active Comparator: Saline, High Pressure Procedure: Saline Solution
Irrigation with Saline
Procedure: 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.

Active Comparator: Soap, Gravity Flow Procedure: Soap solution
Irrigation with Castile Soap Solution (80 ml per 3L bag of saline)
Procedure: 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.
Active Comparator: Soap, low pressure Procedure: Soap solution
Irrigation with Castile Soap Solution (80 ml per 3L bag of saline)
Procedure: 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.

Active Comparator: Soap, high pressure Procedure: Soap solution
Irrigation with Castile Soap Solution (80 ml per 3L bag of saline)
Procedure: 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.


  Eligibility

Ages Eligible for Study:   14 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00788398

  Show 31 Study Locations
Sponsors and Collaborators
Greenville Hospital System University Medical Center
McMaster University
Investigators
Principal Investigator: Kyle J. Jeray, MD Greenville Hospital System
Principal Investigator: Bradley Petrisor, MD Hamilton Health Sciences Corporation
Principal Investigator: Mohit Bhandari, MD McMaster University
Principal Investigator: Gordan Guyatt, M.D. McMaster University
  More Information

No publications provided by Greenville Hospital System University Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Greenville Hospital System University Medical Center
ClinicalTrials.gov Identifier: NCT00788398     History of Changes
Other Study ID Numbers: GHS-03-08-06, W81XWH-08-1-0473
Study First Received: November 7, 2008
Last Updated: October 31, 2013
Health Authority: United States: Institutional Review Board
Canada: Ethics Review Committee

Additional relevant MeSH terms:
Fractures, Bone
Fractures, Open
Wounds and Injuries

ClinicalTrials.gov processed this record on July 23, 2014