Comparative study of the effect of subcutaneous washing with serum gentamicin and normal serum saline in preventing wound infection following appendectomy
The aim of this study is to determine the effect of subcutaneous washing with gentamicin serum in preventing wound infection following appendectomy.
Design
This study is a randomized, clinical trial that will be performed on 120 appendicitis patients referring to the Neyshabour 22 Bahman Hospital. First, patients will be examined for inclusion criteria and Exclusion criteria. Then, eligible patients will be selected by available sampling method. They will be randomly divided into two groups: normal saline and gentamicin.
Settings and conduct
This study is a randomized, clinical trial that will be performed on 120 appendicitis patients referring to the Neyshabour 22 Bahman Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Appendicitis candidate; age range 10-50 years old; resident of Neishabur; and absence of cardiovascular and diabetes; Exclusion criteria: Complications of appendicitis; Corticosteroid use; Smoking and obesity.
Intervention groups
In the normal saline group after removing the appendix, half-liter of normal saline will be used to wash the subcutaneous tissue. In the gentamicin group, after removing the appendix, the subcutaneous tissue will be washed with normal saline and gentamicin (half a liter of normal saline with 80 mg gentamicin).
Main outcome variables
The researcher after operation will examines patients for ulcerative infection as long as they are admitted to the hospital by checking and checklist form with the physician verifying, and from the time of discharge to 30 days after surgery with telephoning control. It is also requested that patients to refer to the hospital's clinic in case any abnormal signs so that the doctor can disclose the presence or absence of infection.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170921036302N4
Registration date:2018-05-11, 1397/02/21
Registration timing:retrospective
Last update:2018-05-11, 1397/02/21
Update count:0
Registration date
2018-05-11, 1397/02/21
Registrant information
Name
sadigheh Khalili Shomia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4401 8328
Email address
khalilis@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Governmental
Expected recruitment start date
2017-04-25, 1396/02/05
Expected recruitment end date
2017-08-27, 1396/06/05
Actual recruitment start date
2017-04-25, 1396/02/05
Actual recruitment end date
2017-08-27, 1396/06/05
Trial completion date
empty
Scientific title
Comparative study of the effect of subcutaneous washing with serum gentamicin and normal serum saline in preventing wound infection following appendectomy
Public title
Effect of subcutaneous washing with gentamicin serum on prevention of wound infection following appendectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Appendicitis candidate
Age range 10-50 years old
Resident of Neishabur
Absence of cardiovascular and diabetes
Exclusion criteria:
Complications of appendicitis
Taking corticosteroids
Smoking and obesity
Age
From 10 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
More than 1 sample in each individual
Number of samples in each individual:
1
One example
Actual sample size reached:
120
More than 1 sample in each individual
Actual sample size in each individual:
1
One example
Randomization (investigator's opinion)
Randomized
Randomization description
Participants in the study will be selected by available sampling method then will be divided to intervention and control groups by randomization software (www.randomizer.com).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Collegiate Paradise, Sabzevar University of Medical Sciences, Sabzevar, Khorasan Razavi
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Approval date
2017-03-13, 1395/12/23
Ethics committee reference number
ir.medsab.rec.1395.134
Health conditions studied
1
Description of health condition studied
Infections of the skin and subcutaneous tissue
ICD-10 code
L00-L08
ICD-10 code description
Infections of the skin and subcutaneous tissue
Primary outcomes
1
Description
Incidence of wound infection after appendectomy
Timepoint
After surgery up to 30 days after discharge
Method of measurement
Check list
Secondary outcomes
empty
Intervention groups
1
Description
In the normal saline group after removing the appendix, half-liter of normal saline will be used to wash the subcutaneous tissue.
Category
Prevention
2
Description
In the gentamicin group, after removing the appendix, the subcutaneous tissue will be washed with normal saline and gentamicin (half a liter of normal saline with 80 mg gentamicin).