Evaluation of prophylactic antibiotic effectiveness in prevention of wound infection in Lichtenstein inguinal hernioplasty with mesh in patients referring Sari,s ImamKhomeini and Qaemshahr,s Razi hospitals
“Evaluation of prophylactic antibiotic effectiveness in prevention of wound infection in Lichtenstein inguinal hernioplasty with mesh”
Background and purpose:
Inguinal hernioplasty is one of the most surgical operations. The use of prophylactic antibiotic in Lichtenstein hernioplasty is controversial. Hence this study done to evaluate the prophylactic antibiotic effect in reducing the post operative wound infection in Lichtenstein hernioplasty.
Material and Methods:
This is an interventional double-blind randomized trial on 282 patients under going, Unilateral primary elective inguinal hernioplasty with Lichtenstein method. Using polypropylene mesh.
They were randomized to receive 1gr/1v cephalotin (keflin) or equal volume of placebo 30min before incision. Patients were evaluated 1week, 2weeks and 12weeks after surgery by an independent surgeon or resident. Wound infection was defined according to the criteria of centers for Disease control and recorded. Results were assessed using chi-square and t-test as appropriate.
Includation criterion: any patient suffering from inguinal hernia undergone elective lichtenstein hernioplasty
Excludation criteria:
1.urgent hernia repair due to incarceration or strangulation
2.recurrent hernia
3.allergy to keflin or penicillins
4.need to use antibiotics due to other preoperation reasons; for example: valvular heart disease or infectious diseases
5.immunosuppression
6.the patient refuses to participate in clinical trial
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201203121786N4
Registration date:2012-06-10, 1391/03/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-06-10, 1391/03/21
Registrant information
Name
Nasrin Rahmani
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1226 1700
Email address
nrahmani@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2010-06-10, 1389/03/20
Expected recruitment end date
2011-12-22, 1390/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of prophylactic antibiotic effectiveness in prevention of wound infection in Lichtenstein inguinal hernioplasty with mesh in patients referring Sari,s ImamKhomeini and Qaemshahr,s Razi hospitals
Public title
Evaluation of prophylactic antibiotic effectiveness in prevention of wound infection in lichtenstein hernioplasty with mesh.
Purpose
Health service research
Inclusion/Exclusion criteria
Includation criterion: any patient suffering from inguinal hernia undergone elective lichtenstein hernioplasty
Excludation criteria: 1.urgent hernia repair due to incarceration or strangulation
2.recurrent hernia
3.allergy to keflin or penicillins
4.need to use antibiotics due to other preoperation reasons; foe example: valvular heart disease or infectious diseases
5.immunosuppression
6.the patient refuses to participate in clinical trial
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
282
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran University of Medical Sciences
Street address
Sari- Imam SQ
City
Sari
Postal code
Approval date
2010-06-09, 1389/03/19
Ethics committee reference number
8933
Health conditions studied
1
Description of health condition studied
inguinal hernia
ICD-10 code
k40.9
ICD-10 code description
Unilateral or unspecified inguinal hernia, without obstruction or gangrene
Primary outcomes
1
Description
Wound infection
Timepoint
One, 2 and 12 weeks postoperation
Method of measurement
Clinical exam and culture
Secondary outcomes
empty
Intervention groups
1
Description
in casegroupe 1gr keflin 30 min before surgery
Category
Prevention
2
Description
and in control group distilled water 30min before surgery
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sari Imam Khomeini hospital
Full name of responsible person
Mohammad Kermansaravi- MD
Street address
Sari- Imam Khomeini hospital
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Ahmadali Enayati
Street address
Sari- Mazandaran University of Medical Sciences
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Mohammad Kermansaravi
Position
MD
Other areas of specialty/work
Street address
Imam hospital, sari
City
Sari
Postal code
Phone
+98 15 1225 6329
Fax
Email
mkermansaravi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Nasrin Rahmani
Position
Assistant Professor
Other areas of specialty/work
Street address
Surgery department, Imam Khomeini hospital, Sari
City
Sari
Postal code
Phone
+98 15 1225 6329
Fax
Email
nrahmani@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Kermansaravi
Position
MD
Other areas of specialty/work
Street address
Surgery department, Imam Khomeini hospital, Sari
City
Sari
Postal code
Phone
+98 15 1225 6329
Fax
Email
mkermansaravi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)