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Open fracture wound, comparison between Saline/Soap solution with Irrigation pressure in patients with open fracture wound

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2011/10/002034
Enrollment
2280
Registered
2011-10-03
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Open Fracture Wounds

Interventions

Intervention1: Saline, gravity flow: Active Comparator Interventions: ?Procedure: Saline Solution ?Procedure: Gravity Flow Irrigation : Procedure: Saline Solution Irrigation with Saline Procedure: G

Sponsors

McMaster University
Lead Sponsor
Greenville Hospital System University Medical Center
Collaborator

Eligibility

Inclusion criteria

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) 4.Fracture requiring operative fixation. 5.Provision of informed consent.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
â?¢Re-operation within 12 months post initial surgery to treat an infection, manage a wound healing problem, or promote fracture healing.Timepoint: 12 months—

Secondary

MeasureTime frame
â?¢Patient function and quality of life measured by the Short Form-12 (SF-12) and the EuroQol-5DTimepoint: 12 months—

Countries

Canada, India, Norway, United States of America

Contacts

Public ContactDr Hrishikesh Talukdar

iProcess India

hrishi@iprocess.net

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026