The main objective of this study is to compare wound infection after appendectomy incision closure with or without the use of sutures in the subcutaneous tissues. This study is performed for one year through a randomized clinical trial in general surgery ward of Imam Reza Hospital in Kermanshah. They study patients with clinical diagnosis of appendicitis who will be operated. inclusion criteria: patients are who were operated with clinical diagnosis of appendicitiss. exclusion criteria :Patients with complicated appendicitis (perforated and peritonitis); The underlying diseases (diabetes mellitus, acquired or intrinsic Immunodeficiency); immunosuppressive drugs; inability to follow patients.The number of samples is 208 which are divided into two groups of A and B with 103 and 105 patients respectively. The classifying method for each of the groups A and B is simple random also the patients are randomly assigned to each of the two groups. The operation sites are shaved in all patients before surgery and are operated through appendectomy with Mcburny cut under general anesthesia .In group A, Appendectomy incision closure is performed through separately Subcutaneous suture technique using Vicryl thread and Skin healing with nylon sutures in a vertical mattress and in group B with no subcutaneous sutures and skin closing just like the first group. Patients refer to the clinic four times after operation: third and seventh day, one and three months after to follow up. In the visits, the surgeon will examine the patient for signs of infection, Presence of purulent discharge from the wound, the pain at the wound site, warmth, swelling or erythema and fever.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013082814333N4
Registration date:2013-09-23, 1392/07/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-09-23, 1392/07/01
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2013-12-21, 1392/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing of appendectomy incision closure with and without the use of sutures in the subcutaneous tissue
Public title
Comparing of appendectomy incision closure with the use of sutures in the subcutaneous tissue
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria: patients are who were operated with clinical diagnosis of appendicitis by surgeons. exclusion criteria: Patients with complicated appendicitis (perforated and peritonitis); The underlying diseases (diabetes mellitus, acquired or intrinsic Immunodeficiency); immunosuppressive drugs; inability to follow patients.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
208
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2013-05-06, 1392/02/16
Ethics committee reference number
5393/پ/7/420
Health conditions studied
1
Description of health condition studied
Acute Appendicitis
ICD-10 code
k35
ICD-10 code description
acute appendicitis
Primary outcomes
1
Description
Purulent discharge of the wound
Timepoint
3,7 days, one month and three months after surgery
Method of measurement
visual secretion
2
Description
Pain at the wound site
Timepoint
3,7 days, one month and three months after surgery
Method of measurement
asking the patient
3
Description
warmth in the wound
Timepoint
3,7 days, one month and three months after surgery
Method of measurement
Visual examination of the patient
4
Description
Swelling at the wound site
Timepoint
3,7 days, one month and three months after surgery
Method of measurement
Visual observation of inflation
5
Description
Erythema (redness) at the wound site
Timepoint
3,7 days, one month and three months after surgery
Method of measurement
erythema
6
Description
presence of fever
Timepoint
3,7 days, one month and three months after surgery
Method of measurement
By Thermometers
Secondary outcomes
empty
Intervention groups
1
Description
Appendectomy wound healing is performed through separately Subcutaneous suture technique using Vicryl thread and Skin healing with nylon sutures in a vertical mattress in control group
Category
Treatment - Surgery
2
Description
Appendectomy wound healing without use of subcutaneous sutures and just closing the skin only in intervention Group.