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OpenTrials
Completed

NCT Number: NCT00788398

Fluid Lavage of Open Wounds

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

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Key information

Conditions

Open Fracture Wounds

Age range

14 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Alfred, Prahran, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

Saline solution

Procedure

Irrigation with Saline

Soap solution

Procedure

Irrigation with Castile Soap Solution (80 ml per 3L bag of saline)

Gravity Flow Irrigation

Procedure

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 Irrigation

Procedure

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 Pressure

Procedure

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Patient function and quality of life measured by the Short Form-12 (SF-12) and the EuroQol-5D

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Prisma Health-Upstate

Other

Collaborators

  • McMaster University
  • United States Department of Defense

Registry information

Official study title

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

Acronym: FLOW

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Nov 10, 2008
Registry last updated
Feb 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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