Fluid Lavage of Open Wounds

Not Applicable

Completed

• Conditions: Open Fracture Wounds
• Interventions: Procedure: Soap solution; Procedure: Saline Solution; Procedure: Gravity Flow Irrigation; Procedure: Low Pressure Irrigation; Procedure: High Pressure

• Registration Number: NCT00788398
• Lead Sponsor: Prisma Health-Upstate

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-11-07
• Study First Submitted QC: 2008-11-07
• Study First Posted: 2008-11-10
• Study Start: 2009-06
• Primary Completion: 2015-01
• Study Completion: 2015-04
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-10
• Last Update Posted: 2016-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2540

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Soap, high pressure	Soap solution	-
Saline, gravity flow	Saline Solution	-
Saline, gravity flow	Gravity Flow Irrigation	-
Saline, High Pressure	Saline Solution	-
Soap, Gravity Flow	Gravity Flow Irrigation	-
Saline, Low Pressure	Saline Solution	-
Soap, Gravity Flow	Soap solution	-
Soap, low pressure	Soap solution	-
Saline, Low Pressure	Low Pressure Irrigation	-
Saline, High Pressure	High Pressure	-
Soap, low pressure	Low Pressure Irrigation	-
Soap, high pressure	High Pressure	-

Primary Outcome Measures

Name	Time	Method
Re-operation within 12 months post initial surgery to treat an infection, manage a wound healing problem, or promote fracture healing.	within 12 months

Secondary Outcome Measures

Name	Time	Method
Patient function and quality of life measured by the Short Form-12 (SF-12) and the EuroQol-5D	12 months

Trial Locations

Locations (31)

Orthopaedic Associates of Michigan; 🇺🇸 Grand Rapids, Michigan, United States

Greenville Hospital System; 🇺🇸 Greenville, South Carolina, United States

Queen Elizabeth II Health Sciences Center; 🇨🇦 Halifax, Nova Scotia, Canada

McMaster University; 🇨🇦 Hamilton, Ontario, Canada

Ulleval University Hospital; 🇳🇴 Oslo, Norway

Univeristy of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Wishard Health Services, Indiana University; 🇺🇸 Indianapolis, Indiana, United States

University of California-Irvine; 🇺🇸 Orange, California, United States

University of California- San Francisco; 🇺🇸 San Francisco, California, United States

Hennepin County Medical Center; 🇺🇸 Minneapolis, Minnesota, United States

Lahey Clinic; 🇺🇸 Burlington, Massachusetts, United States

University of Missouri Health Care; 🇺🇸 Columbia, Missouri, United States

St. Louis University; 🇺🇸 St. Louis, Missouri, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

Miami Valley Hospital/Wright State University; 🇺🇸 Dayton, Ohio, United States

Brooke Army Medical Center; 🇺🇸 Fort Sam Houston, Texas, United States

University of Pittsburg; 🇺🇸 Pittsburg, Pennsylvania, United States

Health Sciences Winnipeg; 🇨🇦 Winnipeg, Manitoba, Canada

Royal Columbian Hospital-New Wesminster; 🇨🇦 New Westminster, British Columbia, Canada

The Alfred; 🇦🇺 Prahran, Australia

London Health Sciences; 🇨🇦 London, Ontario, Canada

Hamilton Health Sciences; 🇨🇦 Hamilton, Ontario, Canada

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

McGill University Health Centre; 🇨🇦 Montreal, Quebec, Canada

Ottawa Hospital- Civic; 🇨🇦 Ottawa, Ontario, Canada

Hôpital de l'Enfant-Jésus; 🇨🇦 Quebec, Canada

Hospital du Sacre-Coeur de Montreal; 🇨🇦 Montreal, Quebec, Canada

Université de Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada

Sancheti Institute; 🇮🇳 Prune, India

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada