Efficacy of topical atorvastatin‐loaded emulgel and nano‐emulgel 1% on post‐laparotomy pain and wound healing: A randomized double‐blind placebo‐controlled clinical trial

Abstract

This study aimed to develop atorvastatin-loaded emulgel and nano-emulgel dosage forms and investigate their efficiency on surgical wound healing and reducing post-operative pain. This double-blind randomized clinical trial was conducted in a surgical ward of a tertiary care hospital affiliated with university of medical sciences. The eligible patients were adults aged 18 years or older who were undergoing laparotomy. The participants were randomized in a 1:1:1 ratio to one of three following groups of atorvastatin-loaded emulgel 1% (n = 20), atorvastatin-loaded nano-emulgel 1% (n = 20), and placebo emulgel (n = 20) twice a day for 14 days. The primary outcome was the Redness, Edema, Ecchymosis, Discharge, and Approximation (REEDA) scores to determine the rate of wound healing. The Visual Analogue Scale (VAS) and quality of life were the secondary outcomes of this study. A total of 241 patients assessed for eligibility; of them, 60 patients completed the study and considered for final evaluation. A significant decrease in REEDA score was observed on Days 7 (63%) and 14 (93%) of treatment with atorvastatin nano-emulgel (p-value < 0.001). A significant decrease of 57% and 89% in REEDA score was reported at Days 7 and 14, respectively, in atorvastatin the emulgel group (p-value < 0.001). Reduction in pain VAS in the atorvastatin nano-emulgel was also recorded at Days 7 and 14 of the intervention. The results of the present study suggested that both topical atorvastatin-loaded emulgel and nano-emulgel 1% were effective in acceleration of wound healing and alleviation of pain of laparotomy surgical wounds, without causing intolerable side effects.