Objectives: The purpose of this study is to evaluate the effect of retention sutures on wound dehiscence following emergent abdominal laparotomy.
Design: Block randomization, with control group, trial phase 2, including 160 patients under emergent abdominal laparotomy due to peritonitis or trauma.
Setting and conduct: Fascia is continuously repaired using a running looped #1 nylon suture.
Participants including major eligibility criteria: 160 patients under emergent abdominal laparotomy due to peritonitis or trauma.
Intervention: Retention sutures that included the skin, subcutaneous tissue, rectus muscle, and abdominal fascia.
Main outcome measures: Wound dehiscence, duration of hospitalization, number of ICU admissions.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015052322385N1
Registration date:2015-07-11, 1394/04/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-07-11, 1394/04/20
Registrant information
Name
Maryam Panahi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3506
Email address
m.panahi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences, Vice Chancellor for Research
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-06-22, 1394/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of retention and routine sutures on wound dehiscence in patients candidate for emergent abdominal laparotomy
Public title
Effect of retention sutures on wound dehiscence of abdominal surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients under emergent abdominal laparotomy due to peritonitis or trauma; The minimum length of 10 cm for incision surgery; Having two known risk factor for wound dehiscence.
Exclusion criteria: Patients who died within two weeks after surgery.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients will divided into 2 groups by block randomization.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences. Basij Square. Sardasht. Arak. Iran
City
Arak
Postal code
Approval date
2014-09-23, 1393/07/01
Ethics committee reference number
92-157-4
Health conditions studied
1
Description of health condition studied
Open wound
ICD-10 code
S31.1
ICD-10 code description
Open wound of abdominal wall
Primary outcomes
1
Description
Wound dehiscence
Timepoint
In days 2, 7, and 14 after discharge
Method of measurement
Wound examination
2
Description
Duration of hospitalization
Timepoint
From the onset of study since the discharge
Method of measurement
Number of days of hospitalization
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Retention sutures that included the skin, subcutaneous tissue, rectus muscle, and abdominal fascia.
Category
Prevention
2
Description
Control group: Without retention sutures.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali asr hospital
Full name of responsible person
Maryam Panahi
Street address
Vali asr hospital. Vali asr square. Arak. Iran
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences, Vice Chancellor for Research
Full name of responsible person
Dr Ali Asghar Yaghoobi
Street address
Arak University of Medical Sciences. Basij Square. Sardasht. Arak. Iran
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences, Vice Chancellor for Research
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
Arak University of Medical Sciences
Full name of responsible person
Maryam Panahi
Position
General surgery resident
Other areas of specialty/work
Street address
Arak University of Medical Sciences. Basij Square. Sardasht. Arak. Iran
City
Arak
Postal code
Phone
+98 86 3417 3641
Fax
Email
maryam.neda.panahi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Maryam Panahi
Position
General surgery resident
Other areas of specialty/work
Street address
Arak University of Medical Sciences. Basij Square. Sardasht. Arak. Iran
City
Arak
Postal code
Phone
+98 86 3417 3641
Fax
Email
maryam.neda.panahi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Maryam Panahi
Position
General surgery resident
Other areas of specialty/work
Street address
Arak University of Medical Sciences. Basij Square. Sardasht. Arak. Iran
City
Arak
Postal code
Phone
+98 86 3417 3641
Fax
Email
maryam.neda.panahi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)