Protocol summary
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Study aim
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Comparison of the effect of simple topical and nano-local atorvastatin formulations on surgical laparotomy wound healing
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Design
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This triple-blind clinical trial randomized in phase 3 was performed with parallel groups of 60 patients (20 per group). The first group receiving atorvastatin nano-emulgel, the second group receiving simple atorvastatin emulgel, and the third group receiving placebo emulgel. Number randomization was performed using Random Allocation software using the permutation block method. Patients will receive the drug twice a day for fourteen days.
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Settings and conduct
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Surgery unit of Dr. Rahnemoon Hospital of Yazd
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Participants/Inclusion and exclusion criteria
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inclusion criteria:
1) Candidates for laparotomy surgery
2) Sufficient literacy to fill out a consent form, understand the study, use the drug, and report pain and possible side effects
Exclusion criteria:
1) Pregnant and lactating women
2) Patients with any peripheral or central neuropathic pain
3) Patients with a history of alcohol abuse or opioid dependence
4) Patients with a history of psychosis
5) Patients with a history of inflammatory disease who cannot discontinue NSAIDs or analgesics.
6) Patients with oral atorvastatin
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Intervention groups
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Group 1: Patients treated with atorvastatin nano emulgel 1%
The second group: patients treated with atorvastatin emulgel 1%
Group 3: Patients treated with placebo
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Main outcome variables
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Redness
Edema
Ecchymosis
Wound size
Wound Secretion
General information
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Reason for update
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The need for some changes during the trial
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190810044500N3
Registration date:
2020-04-10, 1399/01/22
Registration timing:
registered_while_recruiting
Last update:
2023-03-14, 1401/12/23
Update count:
1
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Registration date
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2020-04-10, 1399/01/22
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-11-13, 1398/08/22
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Expected recruitment end date
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2020-07-22, 1399/05/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluation of therapeutic effects of topical atorvastatin in postoperative ulcers: A randomized triple-blind placebo-controlled trial
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Public title
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Effect of atorvastatin on ulcer
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Candidates for laparotomy surgery over 18 years old
Sufficient literacy to fill out a consent form, understand the study, use the drug, report pain and possible side effects
Exclusion criteria:
Pregnant and lactating women
Patients with any peripheral or central neuropathic pain
Patients with a history of psychosis
Patients with a history of inflammatory disease who cannot discontinue NSAIDs or analgesics.
Patients with oral atorvastatin
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Age
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From 18 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-11-03, 1398/08/12
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Ethics committee reference number
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IR.SSU.MEDICINE.REC.1398.196
Health conditions studied
1
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Description of health condition studied
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Post-operative wounds
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Redness
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Timepoint
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Before the start of the intervention - The first day -The seventh day -The fourteenth day
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Method of measurement
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Redness, Oedema, Ecchymosis, Discharge, Approximation (REEDA) scale
2
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Description
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Oedema
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Timepoint
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Before the start of the intervention - The first day -The seventh day -The fourteenth day
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Method of measurement
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REEDA Scale
3
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Description
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Ecchymosis
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Timepoint
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Before the start of the intervention - The first day -The seventh day -The fourteenth day
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Method of measurement
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REEDA Scale
4
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Description
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Wound Secretion
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Timepoint
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Before the start of the intervention - The first day -The seventh day -The fourteenth day
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Method of measurement
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REEDA Scale
5
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Description
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Approximation
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Timepoint
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Before the start of the intervention - The first day -The seventh day -The fourteenth day
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Method of measurement
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REEDA Scale
Secondary outcomes
1
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Description
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Quality of Life
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Timepoint
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On days 1, 7 and 14
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Method of measurement
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According to the Quality of Life Questionnaire of the European Organization for Research and Treatment of Cancer (EORTC QLQ-C30 (version 3)
2
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Description
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visual analog scale (VAS)
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Timepoint
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baseline, days 1, 2, , and 14
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Method of measurement
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The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')
3
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Description
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unexpected adverse effects
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Timepoint
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At the end of the study
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Method of measurement
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Examining and asking the patient
Intervention groups
1
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Description
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Intervention group: Atorvastatin Emulgel
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Category
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Treatment - Drugs
2
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Description
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Control group: Placebo Emulgel
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Category
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Placebo
3
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Description
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Intervention group: Atorvastatin Nano-Emulgel
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Shahid Sadoughi University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available