Abstract: Three small RCTs met our inclusion criteria and included a total of 148 participants. These compared three treatments with topical phenytoin: hydrocolloid dressings, triple antibiotic ointment and simple dressings. In the three RCTs, 79% of participants had grade II ulcers, and 21% of participants had grade I ulcers; no participants had grade III or IV ulcers. Two RCTs had a high risk of bias overall and the other RCT was at unclear risk of bias due to poor reporting. Two RCTs had three intervention arms and the other had two intervention arms. Two studies compared topical phenytoin with hydrocolloid dressing (84 participants analysed). The available data suggest that hydrocolloid dressings may improve ulcer healing compared to topical phenytoin (39.3% ulcers healed for phenytoin versus 71.4% ulcers healed for hydrocolloid dressings (RR 0.55, 95% CI 0.33 to 0.92; 56 participants, 1 study; low quality evidence). We downgraded the evidence twice: once due to serious limitations (high risk of bias) and once due to the small sample size and small number of events. Two studies compared topical phenytoin with simple dressings (81 participants analysed). From the available data, we are uncertain whether topical phenytoin improves ulcer healing compared to simple dressings (39.3% ulcers healed for phenytoin versus 29.6% ulcers healed for the simple dressing (RR 1.33, 95% CI 0.63 to 2.78; 55 participants, 1 study; very low quality evidence). This evidence was downgraded once due to serious limitations (high risk of bias) and twice due to the low number of outcome events and resulting wide CI which included the possibility of both increased healing and reduced healing. We therefore considered it to be insufficient to determine the effect of topical phenytoin on ulcer healing. One study compared topical phenytoin with triple antibiotic ointment, however, none of the outcomes of interest to this review were reported. No adverse drug reactions or interactions were detected in any of the three RCTs. Minimal pain was reported in all groups in one trial that compared topical phenytoin with hydrocolloid dressings and triple antibiotic ointment. This review has considered the available evidence and the result shows that it is uncertain whether topical phenytoin improves ulcer healing for patients with grade I and II pressure ulcers. No adverse events were reported from three small trials and minimal pain was reported in one trial. Therefore, further rigorous, adequately powered RCTs examining the effects of topical phenytoin for treating pressure ulcers, and to report on adverse events, quality of life and costs are necessary.

Plain-language summary: In September 2016 we searched for randomised controlled trials (RCTs) that compared topical phenytoin against other treatments for treating pressure ulcers. We found three small RCTs that included a total of 148 people with pressure ulcers. The average age of participants in two studies was 45 years and 75 years in one study. Twenty-one per cent of participants had grade I ulcers (the least severe type, with swollen but unbroken skin) and 79% had grade II ulcers (slightly more severe). No one had grade III or IV ulcers (the most severe types). The trials compared topical phenytoin with three other treatments for pressure ulcers: hydrocolloid dressings, triple antibiotic ointment, and simple dressings. The results of one study suggested that hydrocolloid dressings may slightly improve ulcer healing compared to topical phenytoin. However, we are uncertain whether topical phenytoin improves ulcer healing compared to simple dressings. The study which compared topical phenytoin with triple antibiotic ointment did not report any outcomes of interest to this review. It is uncertain whether topical phenytoin improves ulcer healing for patients with grade I and II pressure ulcers. No adverse events were reported from three small trials and minimal pain was reported in one trial. The trials did not report on some other measurements that we were interested in, such as cost of treatment and quality of life. Two RCTs had a high risk of bias overall, which might have affected the results, and another RCT did not report sufficient details about how it was conducted. Further rigorous, adequately powered RCTs are needed to find whether topical phenytoin is a helpful medication for treating pressure ulcers. This plain language summary is up to date as of September 2016.