Diphoterine® in therapeutic care of chemical burn: To recommend or not to recommend?

Abstract

Diphoterine ® (Prevor Company, France) is an amphoteric hypertonic solution proposed for decontamination in case of cutaneous or ocular corrosive injury. Our Poison Information Center of Lyon (PIC Lyon) is regularly questioned by occupational health professionals about the benefit of diphoterine®. As new studies became available since the last review of Brent [1] , our aim was to assess systematically the available evidence on diphoterine ® . Non clinical studies and randomized or non-randomized trials in humans assessing the benefit of diphoterine ® after cutaneous or ocular chemical burns were eligible. We searched Medline, Google and the Prevor website. After screening title and abstracts, relevant articles were selected, and the following data were extracted: study characteristics including quality assessment, type of controls and clinical outcomes (such as healing delay, burn severity), presence of potential conflict of interest. We identified 37 articles or abstracts of whom 12 original studies (6 sponsored by Prevor company) were included. Five controlled studies were conducted in animals (ocular exposures in three and skin in two). Sample size ranged from 16 to 30 animals. Two studies (one randomized) suggested an effect of diphoterine ® use on ocular pH but not on clinical outcomes; one randomized study suggested a decrease of corneal injury; one randomized study observed a complete or almost complete healing of the burn injury in the five rats treated with diphoterine ® compared to a detersion of eschar or a wound re-epithelization in the five rats treated with normal saline solution. However, these last studies reported multiple outcomes, without defining a principal, and did not correct for multiple testing. The last study, assessing the safety of diphoterine ® , did not detect hypersensitivity reactions after skin exposure. Seven studies were conducted in humans with both eye and skin exposures. Sample size ranged from 5 to 180. Of the 3 retrospectives cases series, one uncontrolled study (24 subjects) did not detect adverse effects attributable to diphoterine ® decontamination; one uncontrolled study (34 subjects) suggested a decrease in pain; the controlled study (131 subjects) did not show a decrease in the time to healing as compared to water (9.0 days in the diphoterine ® group versus 7.0 in the non-diphoterine ® group, P = 0.258). Of the 4 prospective studies, one was uncontrolled (5 subjects) and 3 compared diphoterine ® to water and/or saline solution (from 65 to 180 subjects). Regarding the three controlled prospective trials, none of them were randomized; none of them controlled the alpha risk when reporting multiple outcomes; they suggested clinical benefits with less serious burns, decrease in pain or shorter time for recovery. We did not find acceptable level of evidence suggesting a clinical benefit of diphoterine ® . Observations reported in the prospective clinical trials were at high risk of bias and at high risk of false positive results. Our results are consistent with previous systematic review [1] , [2] , [3] . We did not assess the financial cost of diphoterine ® . Compared to water or saline solution, the benefit of decontamination with diphoterine ® is questionable. We believe that the decontamination should be performed as early as possible with the most easily accessible solution, and water should be the first option.