Fluid Lavage of Open Wounds

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

Conditions

• Open Fracture Wounds

Interventions

PROCEDURE

Saline Solution

Irrigation with Saline

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.

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.

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.

Sponsors & Collaborators

• McMaster University

  collaborator OTHER

• United States Department of Defense

  collaborator FED

• Prisma Health-Upstate

  lead OTHER

Principal Investigators

• Kyle J. Jeray, MD · Greenville Hospital System

• Bradley Petrisor, MD · Hamilton Health Sciences Corporation

• Mohit Bhandari, MD · McMaster University

• Gordan Guyatt, M.D. · McMaster University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

FACTORIAL

Eligibility

Min Age

14 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-06-30

Primary Completion

2015-01-31

Completion

2015-04-30

Countries

• United States
• Australia
• Canada
• India
• Norway

Study Locations