Fluid Lavage of Open Wounds (FLOW)

Prisma Health-Upstate

Status: Completed

Conditions: Open Fracture Wounds

Treatments: Procedure: Soap solution; Procedure: Gravity Flow Irrigation; Procedure: High Pressure; Procedure: Saline Solution; Procedure: Low Pressure Irrigation

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00788398

GHS-03-08-06

W81XWH-08-1-0473

Details and patient eligibility

About

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

Enrollment: 2,540 patients

Sex: All

Ages: 14 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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2,540 participants in 6 patient groups

Saline, gravity flow

Active Comparator group

Treatment:

Procedure: Gravity Flow Irrigation

Procedure: Saline Solution

Saline, Low Pressure

Active Comparator group

Treatment:

Procedure: Low Pressure Irrigation

Procedure: Saline Solution

Saline, High Pressure

Active Comparator group

Treatment:

Procedure: High Pressure

Procedure: Saline Solution

Soap, Gravity Flow

Active Comparator group

Treatment:

Procedure: Soap solution

Procedure: Gravity Flow Irrigation

Soap, low pressure

Active Comparator group

Treatment:

Procedure: Soap solution

Procedure: Low Pressure Irrigation

Soap, high pressure

Active Comparator group

Treatment:

Procedure: Soap solution

Procedure: High Pressure