Fluid Lavage of Open Wounds (FLOW): Pilot Trial

McMaster University

Status: Completed

Conditions: Infection; Wound Healing Problem; Nonunion

Treatments: Procedure: Type of fluid lavage solution; Procedure: Type of fluid lavage pressure

Study type: Interventional

Funder types: Other

Identifiers

NCT01069315

05-299

Details and patient eligibility

About

The purpose of this trial is to investigate whether irrigation solution (soap vs. saline solution), or irrigation pressure (high vs. low) will decrease the rate of infection among patients with open fracture wounds.

Full description

Open fractures are an important source of morbidity and are associated with delayed union, nonunion, and infection. Preventing infection through meticulous irrigation and debridement is an important goal in management, and different lavage fluids and irrigation techniques (e.g. high or low pressure lavage) have been described for this purpose. There are, however, a limited number of randomized trials comparing irrigating solutions or irrigating technique. We compared the use of castile soap versus normal saline, as well as high versus low pressure pulsatile lavage on the rates of reoperations and complications in patients with open fracture wounds.

Enrollment: 111 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• skeletally mature
• sustained an open fracture of the appendicular skeleton (type I to IIIb).

Exclusion criteria

• vascular deficit
• [any] allergy to detergents or castile soap
• previous wound infection or osteomyelitis
• previous fracture with retained hardware in the injured extremity
• operative management more than 24 hours after injury
• use of immunosuppressive medication within six months
• immunological deficiency or disease conditions
• fractures of the hands (distal to the carpus) or toes

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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111 participants in 4 patient groups

Normal saline and High pressure

Experimental group

Description:

Irrigation with normal saline delivered at high pressure

Treatment:

Procedure: Type of fluid lavage pressure

Procedure: Type of fluid lavage solution

Soap solution and High pressure

Experimental group

Description:

Irrigation with soap solution delivered at high pressure

Treatment:

Procedure: Type of fluid lavage pressure

Procedure: Type of fluid lavage solution

Normal saline and Low pressure

Experimental group

Description:

Irrigation with saline solution delivered at low pressure

Treatment:

Procedure: Type of fluid lavage pressure

Procedure: Type of fluid lavage solution

Soap solution and Low pressure

Experimental group

Description:

Irrigation with soap solution delivered at low pressure

Treatment:

Procedure: Type of fluid lavage pressure

Procedure: Type of fluid lavage solution