Protocol summary

Summary
Introduction: Appendectomy is the most common surgical emergenc worldwide. Approximately 7% of all people undergone appendectomy for acute appendicitis in their lifetime, and therefore improving aesthetic results of scar without increasing complications was always at the point of attension. The aim of this study was to campare the wound healing and complications of absorbable subcoticular suturing with steri-strips and interrupted suturing in uncomplicated appendicitis. Methods: This study was designed az a randomized controlled clinical trial in Beasat hospital of Hamedan and peformed over a period of 8 months,on patients which were candidated for emergent appendectomy and had non complicated appendicitis. 70 patients were randomly divided into two groups. 35 cases were under gone appendectomy and wound repair with absorbable subcoticular suturing and steri-strips. The other group was repaired with non absorbable interrupted suturing.Groups were fllowed up among 3 months and infection and wound abcsess rate, wound dehisence, scar width, Patient satisfaction of scar and VAS of pain were compared in two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013040812948N1
Registration date: 2013-05-29, 1392/03/08
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-05-29, 1392/03/08
Registrant information
Name
Ali Moin Lashkajani
Name of organization / entity
Hamedan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 6293
Email address
ali.moein@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Science
Expected recruitment start date
2012-10-22, 1391/08/01
Expected recruitment end date
2013-06-22, 1392/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of wound healing and complications of absorbable subcoticular suturing with steri-strips method with interrupted suturing method in uncomplicated appendicitis wound.
Public title
Comparison of wound healing and complications of absorbable subcoticular suturing with steri-strips method with interrupted suturing method in uncomplicated appendicitis wound.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All patients which candidate for appendectomy. and were entered in study after being informed about the study and receiving Informed consent. Exclusion criteria: perforated appendicitis, Gangrenous appendicitis, phlegmon of appendicitis, underlying disease such as diabetes،acquired or primary immunosuppression, difficulty in following patients
Age
No age limit
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size: 70
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
Hamedan University of Medical Science
Street address
Hamedan University of Medical Science, Medicine Faculty
City
Hamedan
Postal code
Approval date
2012-10-20, 1391/07/29
Ethics committee reference number
16/35/9/2558/پ/د

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
surgical site infection
Timepoint
at addmission, one week, one months, 3 months later
Method of measurement
physical examination

2

Description
wound dehicence
Timepoint
at addmission, one week, one months, 3 months later
Method of measurement
physical examination

3

Description
scar width
Timepoint
3 months later
Method of measurement
millimeter

4

Description
abcsess of wound site
Timepoint
at addmission, one week, one months, 3 months later
Method of measurement
physical examination

Secondary outcomes

1

Description
patient satisfaction
Timepoint
at addmision, one month and 3 month later
Method of measurement
nominal scale

Intervention groups

1

Description
Intervension group: absorbable subcoticular suturing with steri-strips in uncomplicated appendicitis.
Category
Treatment - Surgery

2

Description
Control group: interrupted suturing in wound of uncomplicated appendicitis.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Besaat hospital
Full name of responsible person
Dr. Ali Moein Lashkajani
Street address
Resaalat Sq,Hamadan,Iran
City
Hamedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Science
Full name of responsible person
Research deputy
Street address
Hamedan University of Medical Science,shahid fahmideh st,Hamadan,Iran
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Science
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
Hamedan University of Medical Science
Full name of responsible person
Ali Moein Lashkajani
Position
Resident of general surgery
Other areas of specialty/work
Street address
Besaat hospital,resalat sq,hamadan,iran
City
Hamedan
Postal code
Phone
+98 912 297 7591
Fax
Email
ali.moein@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Science
Full name of responsible person
Ali moein Lashkajani
Position
Resident of general surgery
Other areas of specialty/work
Street address
Beesat hospital,resalat sq,hamadam,iran
City
Hamedan
Postal code
Phone
+98 912 297 7591
Fax
Email
dralimoein@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Science
Full name of responsible person
Nazila Hasanzadeh
Position
Resiident of general surgery
Other areas of specialty/work
Street address
Besaat hospital,resalat sq,hamadan,iran
City
Hamedan
Postal code
Phone
+98 914 401 1305
Fax
Email
nnnnaz2002@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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