Introduction: Chronically hospitalized patients are often burdened with skin ulcerations, which may be persistent and even irreversible. Treatment with hyaluronic acid is widely used in the early phases of the ulcers to relieve symptoms and accelerate the healing process. The present study hypothesized that lysine hyaluronate (Lys-HA) (Lysial(®), Fatai-Nyl Srl; Jasper LLC, Lugano, Switzerland), a new formulation of hyaluronic acid, would improve the healing of decubitus ulcers more than the commonly used sodium hyaluronate (SH). A double-blind randomized controlled trial was designed to assess the superiority of Lys-HA versus SH on decubitus ulcer size reduction over a 15-day period, and on the time necessary to reach 50% lesion size regression.
Methods: After a clinical evaluation, 50 hospitalized patients with decubitus ulcers were divided into three groups according to ulcer stage (stage 1: erythema and edema; stage 2: all-thickness skin destruction; stage 3: destruction of subcutaneous tissue) and randomized to receive Lys-HA or SH. Digital photographs were taken before the start of treatment, then every 3 days, and at the end of the study. Pre- and posttreatment differences in each group were tested using Student t tests and analysis of covariance with basis values as covariates.
Results: Ulcer reduction was greater in all the Lys-HA groups than SH groups. In stage 1 patients, 90% and 70% lesion size reductions were observed in the groups allocated to Lys-HA and SH, respectively (P<0.05). In stage 2 patients, 70% and 40% lesion size reductions were observed in the Lys-HA and SH groups, respectively (P<0.02). In stage 3 patients, 71% and 29% lesion size reductions were observed in the Lys-HA and SH groups, respectively (P<0.01). The regression time of 50% of lesion size was shorter in all the Lys-HA groups than SH groups (P<0.05).
Conclusion: The use of Lys-HA in the healing process of decubitus ulcers provides an improved efficacy with respect to SH in hospitalized patients, suggesting its use from the early phases of ulceration.