SLR - March 2016 - Van Dao
Title: A Trial of Wound Irrigation in the Initial Management of Open Fracture Wounds
Reference: FLOW Investigators, Bhandari M, Jeray KJ, Petrisor BA, Devereaux PJ, Heels-Ansdell D, Schemitsch EH, Anglen J, Della Rocca GJ, Jones C, Kreder H, Liew S, McKay P, Papp S, Sancheti P, Sprague S, Stone TB, Sun X, Tanner SL, Tornetta P 3rd, Tufescu T, Walter S, Guyatt GH. A Trial of Wound Irrigation in the Initial Management of Open Fracture Wounds. N Engl J Med, 2015; 373(27): 2629-2641.
Scientific Literature Review
Reviewed By: Van Dao, DPM
Residency Program: Beaumont Hospital – Farmington Hills
Podiatric Relevance: Podiatric surgeons encounter a wide realm of foot and ankle trauma cases, and the concept of understanding the appropriate management of open fractures is very important. Open fractures are not an uncommon occurrence in the foot and ankle, and treatment for over thirty years has been based upon the Gustilo-Anderson classification system. The guidelines for managing open fractures consist of surgical debridement within six hours, irrigation, antibiotics prophylaxis, and fracture stabilization. The management of open fractures requires wound irrigation and debridement to remove bacterial contaminants, but the effectiveness of numerous pressures and solutions for irrigation remains a debated topic in the field of podiatry. The study had hypothesized that high pressure irrigation would be more effective than low pressure in removing particulate matter and bacteria, and that castile soap acts as an emulsifier and does not have a risk of antibiotic resistance and is less toxic than normal saline. In this particular study, the effects of castile soap versus normal saline irrigation delivered by means of high, low, or very low pressure was observed to determine which method of wound irrigation would be the most effective initial treatment for open fractures.
Methods: This study was an international, blinded, and randomized controlled trial that was conducted at 41 clinical centers using a 2-by-3 factorial design. From June 2009 through September 2013, patients who had an open fracture of an upper or lower extremity that required operative fixation were recruited into the study. These patients were randomly assigned to undergo irrigation with one of the three irrigation pressures; i.e. high pressure (>20 psi), low pressure (5 to 10 psi), or very low pressure (1 to 2 psi), and the patients were also assigned to one of the two irrigation solutions; i.e. castile soap or normal saline. The primary outcome measure was reoperation within 12 months after the index surgery in order to treat the wound infection or to promote for wound or bone healing.
Results: From June 2009 through September 2013, 2551 patients were recruited, but only 2447 patients were eligible for this study and were included in the final analyses. The majority of the patients in this study were men in their 40s and had a lower extremity fracture, likely secondary to a motor vehicle accident. The study used a Cox regression according to the severity of the open fracture with reoperation as the end point in the time-to-event analysis. The primary outcome measure was determined by reoperation within 12 months after the index procedure to treat an infection or to promote wound or bone healing and had occurred in 323 of the 2447 patients. The rate of the primary outcome measure did not show any significant difference according to the type of irrigation pressure depicted in the reoperations that occurred in 109 of 826 patients (13.2 percent) in the high pressure group, 103 of 809 patients (12.7 percent) in the low pressure group, and 111 of 812 patients (13.7 percent) in the very low pressure group. Reoperation occurred in 182 of the 1229 patients (14.8 percent) in the castile soap group and in 141 of 1218 patients (11.6 percent) in the normal saline group, indicating a slightly higher reoperation rate for castile soap over normal saline.
Conclusions: The rates of reoperation did not show any significant difference among the three different types of irrigation pressure. The findings of this study further justified the hypothesis of this study in that very low pressure irrigation could be as effective and act as an acceptable, low-cost alternative for open fractures as a high or low pressure irrigation. In the field of podiatric surgery, understanding the initial management of open fractures with irrigation and debridement is crucial in limiting the number of infections that could subsequently lead to amputations or osteomyelitis in the foot and ankle. This study also concluded that the reoperation rate within 12 months was slightly higher in the castile soap treatment group than in the normal saline treatment group, suggesting that there was no significant difference in the choice of irrigation solution. From a podiatric surgeon’s perspective, understanding that there is no benefit to the use of irrigation-pressure devices can help guide the allocation of limited resources, especially in the management of open fractures in combat settings or in other situations where resources are limited. Overall, this study proved that the effectiveness of the irrigation pressure and solution is negligible for the effective removal of foreign matter and bacteria in order to prevent infection and promote wound or bone healing in all open fractures.