Comparison of the effect of simple topical and nano-local atorvastatin formulations on surgical wound healing
Design
This two-way blind clinical trial randomized in phase 3 was performed with parallel groups on 60 patients. It consists of three groups of 20 people, the first group receiving atorvastatin nano emulgel and the second group receiving simple atorvastatin emulgel and the third group receiving control group (placebo recipient). The randomization was done based on the blockchain table. Patients will receive the drug twice a day for fourteen days.
Settings and conduct
Intensive care units of Dr. Rahnemoon Hospital of Yazd
Participants/Inclusion and exclusion criteria
nclusion criteria:
1) Candidates for various surgeries
2) Sufficient literacy to fill out a consent form, understand the study, use the drug, report pain and possible side effects
Exclusion criteria:
1) Having an underlying disease that prevents the patient from performing generalized anesthesia
2) Not taking the medicine correctly
3) Failure to sign a written consent
4) Pregnant and lactating women
5) Patients with any peripheral or central neuropathic pain
6) Patients with a history of alcohol abuse or opioid dependence
7) Patients with a history of psychosis
8) Patients with a history of inflammatory disease who cannot discontinue NSAIDs or analgesics.
9) Patients with oral atorvastatin
Intervention groups
Group 1: Patients treated with atorvastatin nano emulgel 1%
The second group: patients treated with atorvastatin emulgel 1%
Group 3: Patients treated with placebo
Evaluation of therapeutic effects of topical atorvastatin in postoperative ulcers: A randomized double-blind placebo-controlled trial
Public title
Effect of atorvastatin on ulcer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidates for different surgeries (laparoscopic cholecystectomy, ependectomy, hernia, laparotomy, thyroidectomy and Breast removal) over 18 years
Sufficient literacy to fill out a consent form, understand the study, use the drug, report pain and possible side effects
Exclusion criteria:
Having an underlying disease that prevents the patient from performing generalized anesthesia
Not taking the medicine correctly
Failure to sign a written consent
Pregnant and lactating women
Patients with any peripheral or central neuropathic pain
Patients with a history of alcohol abuse or opioid dependence
Patients with a history of psychosis
Patients with a history of inflammatory disease who cannot discontinue NSAIDs or analgesics.
Patients with oral atorvastatin
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Number randomization was performed using Random Allocation software using permutation block method. The numbers are sorted into three blocks and assigned to the codes A, B and C. That the codes A, B, and C are unknown for the researcher.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Blindness was performed on clinical caregivers, including physicians and nurses, as well as variables assessors and data analysts.In this case, the three drugs nano-emulsifiers of atorvastatin and simple emulsifiers of atorvastatin and placebo with the letters A, B and C are randomly named by another person and this person is not responsible in this study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
insitutional research Ethics Committee school of medicine - shahid sadoughi university of medical sc
Street address
shahid sadoughi university of medical sciences, shohaday gomnam blvd,yazd
City
yazd
Province
Yazd
Postal code
8915173143
Approval date
2019-11-03, 1398/08/12
Ethics committee reference number
IR.SSU.MEDICINE.REC.1398.196
Health conditions studied
1
Description of health condition studied
Post-operative wounds
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Redness
Timepoint
Before the start of the intervention - The first day -The seventh day -The fourteenth day