In this study, we aim to investigate the therapeutic effect of rosuvastatin at the narrowing time (primary wound healing) and epithelialization time (complete wound healing) of surgical wounds.
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized (randomized block design)
Patients were randomly divided into two groups, control group(placebo), intervention group (receiving Composition of Rosuvastatin 2% in .Carboxymethyl cellulose). each group consists of 41 patients
Settings and conduct
Patients referring to the surgical department of Shahid Beheshti Hospital in Qom were randomly divided into two groups, control (receiving placebo) and intervention (receiving the drug). Placebo and the drug are in tubes. the surgical ward nurse is the only one who is aware of tubes containings. The patient and the health care group are not aware of the contents of the tubes. The contents of the tube are used twice daily for 7 days on the wound of patients. The patient will be monitored daily by her/his physician and primary wound healing time, complete healing time (epithelization) and the amount of analgesic will be measured.
Participants/Inclusion and exclusion criteria
participants:
Patients referred to the surgical department of Shahid Beheshti Hospital in Qom who undergo surgery.
inclusion criteria:
1-wounds due to operative incision
exclusion criteria:
1-age below 11 years old
2-malignant wound
3-traumatic wound
4-infectious and dirty wound
5-oral statin consumption
6-opioid addiction
8-comorbidity ( uncontrolled diabetes mellitus, immunosuppression , cirrhosis, renal failure)
Intervention groups
Control group (receiving placebo - Carboxymethyl cellulose )
Intervention group (receiving Rosuvastatin 2% in Carboxymethyl cellulose)
Main outcome variables
1. age
2. gender
3. analgesic usage
4. primary wound healing time
5. complete wound healing (epithelization)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120118008769N2
Registration date:2019-11-02, 1398/08/11
Registration timing:prospective
Last update:2019-11-02, 1398/08/11
Update count:0
Registration date
2019-11-02, 1398/08/11
Registrant information
Name
Seyed Jalal Eshagh Hosseini
Name of organization / entity
Qom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 25171181
Email address
j.hosseini@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-22, 1398/09/01
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Rosuvastatin on operative wounds
Public title
The effect of Rosuvastatin on wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Wounds due to operative incision
Exclusion criteria:
Age below 11 years old
Malignant wound
Traumatic wound
Infectious and dirty wound
Oral statin consumption
Opioid addiction
Comorbidity ( uncontrolled diabetes mellitus, immunosuppression , cirrhosis, renal failure)
Age
From 11 years old
Gender
Both
Phase
0
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
41
Randomization (investigator's opinion)
Randomized
Randomization description
Blast Accident, Random Unit: Individual,
Blinding (investigator's opinion)
Double blinded
Blinding description
After signing the consent, the patient entered the study. Patients and the physician were not aware of the contents of the tube used for the patient.
Placebo
Used
Assignment
Parallel
Other design features
Rosuvastatin 2% will be used in this study
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qom University of Medical Sciences