Saline solution reduces reoperation compared to soap in irrigation of open fractures

Study Type: Randomized Trial
OE Level of Evidence: 1
Journal Level of Evidence: N/A
OE EXCLUSIVE
Dr. Mohit Bhandari discusses the FLOW trial and the necessity for large randomized controlled trials in medicine.
Synopsis
2551 patients with an open fracture of the extremity were included in this randomized, 2 by 3 factorial design trial to investigate the effects of irrigation pressure and solution on reoperation rates. The patients were randomized to receive irrigation with either soap or saline at high, low, or very low pressure. After a 12 Please login to view the rest of this report. Please login to view the rest of this report.
Funding: Non-Industry funded
Sponsor: Canadian Institutes of Health Research, Department of Defense, Association Internationale pour l'Osteosynthese Dynamique, Non-financial support: Stryker provided lavage, Triad provided soap
Conflicts: None disclosed
CONTENT IS LOCKED
Why was this study needed now?
The irrigation of open fractures is necessary to prevent infection and promote wound and bone healing; however, the best practice regarding irrigation pressure and solution remain a controversial topic in the management of these injuries. High pressure irrigation may remove particulate matter more effectively, but might negatively affect bone healing. Nevertheless, there is concern that low pressure may lead to increases in infection rate. There is a strong biological rationale for the use of soap as an irrigation solution; however, no study has effectively compared between differing irrigation pressures and solutions in open fractures.
What was the principal research question?
How does irrigation solution and pressure affect reoperation rate for infection, management of a wound-healing problem, or promotion of bone healing in patients with open fractures of the extremities, when measured over a 12 month period?
Population: 2551 patients over the age of 18 with open fractures of an extremity requiring operative fixation. Perioperative antibiotic use and the minimum amount of solution was standardized according to the severity of the open fracture wound (Gustilo-Anderson classification). Patient allocation: Soap Irrigation (n=1275) vs.Saline Irrigation (n=1276) and very low pressure (n=846) vs. low pressure (n=846) vs. high pressure (n=859)
Intervention: Soap Irrigation (0.45% solution of castile soap) (n=1275) - very low pressure (1 to 2 psi) - low pressure (5 to 10 psi) - high pressure (>20 psi)
Comparison: Saline Irrigation (n=1276) - low pressure (1 to 2 psi) - very low pressure (5 to 10 psi) - high pressure (>20 psi)
Outcomes: The primary endpoint was a composite outcome for reoperation (surgery within 12 months of the initial procedure to treat an infection, manage a wound-healing problem, or promote bone healing). Secondary endpoints included nonoperatively managed infection and wound-healing and bone healing problems within 12 months of index surgery.
Methods: RCT: Multicenter; blinded; 2x3 factorial design. Stratification by study center and Gustilo-Andersen fracture grade (I or II vs. III)
Time: Follow-up at 1, 2, and 6 weeks and 3, 6, 9, and 12 months
What were the important findings?
What should I remember most?
How will this affect the care of my patients?
The authors responsible for this critical appraisal and ACE Report indicate no potential conflicts of interest relating to the content in the original publication.
Farouk Latif
October 21, 2015
null - Egypt
ineresting finding; but how long washing is enough .
Dr. Ortho Evidence
October 21, 2015
Other - Canada
Dear Dr. Farouk Latif, OrthoEvidence thanks you for your comment. The study standardized minimum volumes of irrigation solution based on fracture severity (Gustilo-Anderson Type I fractures: min. 3L; Gustilo-Anderson Types II and III fractures: min. 6L), rather than by amount of time spent irrigating the wound. We realize that this information was not originally reported in the ACE Report, and have since updated the summary in order to reflect the possible questions from OE members related to the protocol. Thank you again for you interest in this ACE Report. The Team at OrthoEvidence