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

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...

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Bibliographic Details
Published in:International wound journal 2023-12, Vol.20 (10), p.4006-4014
Main Authors: Saghafi, Fatemeh, Ramezani, Vahid, Jafari‐Nedooshan, Jamal, Zarekamali, Javad, Kargar, Saeed, Tabatabaei, Seyed Mostafa, Sahebnasagh, Adeleh
Format: Article
Language:English
Subjects:
atorvastatin
Clinical trials
Drug delivery systems
Drug dosages
emulgel
Glycerol
Laparotomy
Nanoemulsions
nano‐emulgel
Pain
Particle size
Patients
post‐laparotomy pain
Quality of life
Questionnaires
Surfactants
Surgeons
Surgery
surgical wounds
Ulcers
Variables
Variance analysis
Viscosity
Wound healing
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Summary: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 
ISSN:1742-4801
1742-481X
DOI:10.1111/iwj.14289