Patients who undergo surgery for appendicitis will be divided in two groups: first group skin will be sewed by conventional method that is Nylon sutures. Second group skin will be sewed by Polyglactine ( Vicryl). The incidence of complications and wound infections in both groups will be compared. Patients in the second and tenth days after surgery are examined and infections of skin incision and wound healing in the two groups will be recorded. The quality of wound healing will be compared with steriotactics software in both groups after 10th days of surgery. In the absence of significant difference between the two groups in the incidence of wound infections, surgeons and assistants can freely choose the suturing materials with a better cosmetic and comfort results. We can use absorbable suture strings that had been remained from suturing of subcutaneous tissue and this method is economically excusable and we will not impose extra costs for extra sutures for skin. Proving the safety and absence of higher risk of infection in applying polyfilament absorbable sutures can open or broader prospective for similar studies in future that imply kinds of sutures in different surgeries.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201501179936N10
Registration date:2015-03-08, 1393/12/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-03-08, 1393/12/17
Registrant information
Name
Leila Ghahramani
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1623 5586
Email address
lghahraman@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellery for Research and Technology, Shiraz University of Medical Sciences, Shiraz, Iran
Expected recruitment start date
2015-01-10, 1393/10/20
Expected recruitment end date
2016-08-04, 1395/05/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of infection incidence between appendectomy skin incisions sutured by Nylon and Polyglactine ( Vicryl)
Public title
Comparison of infection incidence between appendectomy skin incisions sutured by Nylon and Polyglactine ( Vicryl)
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criterion: all patient with diagnosed appendicitis whom are underwent surgery
Exclusion criteria: patients with perforated appendicitis; patients with history of scar and colloid formation in their wounds; patients who have diabetes and immune deficiencies; BMI>40; patients with exposure to steroids.
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
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-Chancellery of Research and Technology, Shiraz University of Medical Sciences, Shiraz, Iran
Street address
Shiraz University of Medical Sciences, Shiraz, Iran
City
Shiraz
Postal code
Approval date
2015-01-06, 1393/10/16
Ethics committee reference number
CT-P-9371-7161
Health conditions studied
1
Description of health condition studied
Appendicitis
ICD-10 code
K35.2
ICD-10 code description
Acute appendicitis with generalized peritonitis
Primary outcomes
1
Description
Wound infection rate
Timepoint
Second post operation day and then one week later
Method of measurement
Clinical diagnosis
Secondary outcomes
1
Description
Wound dehiscence
Timepoint
One week after surgery
Method of measurement
Clinical diagnosis
Intervention groups
1
Description
Control Group: using Nylon (conventional method)
Category
Treatment - Other
2
Description
Trial Group: using vicryl sutures
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Surgery clinic, Shahid Faghihi hospital, Shiraz University of Medical Sciences
Full name of responsible person
Leila Ghahramani. MD
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyed Basir Hashemi
Street address
Shiraz University of Medical Sciences, Shiraz, Iran
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Colorectal Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
Full name of responsible person
Alireza Golchini. MD
Position
Resident of general surgery
Other areas of specialty/work
Street address
Colorectal Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 3628 1453
Fax
Email
sgholchini@yahoo.com; siamakgolchini@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Colorectal Research Center, Shiraz university of medical sciences, Shiraz, Iran
Full name of responsible person
Leila Ghahramani. MD
Position
Colorectal flowship, assistant professor
Other areas of specialty/work
Street address
Colorectal Research Center, Shiraz university of Medical Siences, Shiraz, Iran