The aim of this study was to evaluate the efficacy of preoperative antibiotic prophylaxis in postoperative infection rates in acute appendicitis . This study is a randomized clinical trial of 150 patients with the following inclusion criteria: patients with acute suppurative appendicitis are pleased to participate in the study Exclusion criteria: Patients with a normal appendix, gangrenous, perforated, are included in the study are patients with endocarditis . Patients in the two groups, the first group underwent antibiotic regimen of single-dose metronidazole and ceftriaxone intravenously before surgery and the second group underwent antibiotic regimen of single-dose metronidazole and ceftriaxone intravenously before surgery and two doses postoperatively (Read it after 24 hours surgery) as well. In both groups 24 hours after the dressing was removed and feeding tolerance, good mobility and no fever cleared. Patients treated by a surgeon and the surgical technique (Bernie Mac) is the same for all patients. Within a month after the operation by the surgeon that other colleagues were involved in the operation. The wound infection or abscess treated by clinical examination.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014092219255N1
Registration date:2014-10-02, 1393/07/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-10-02, 1393/07/10
Registrant information
Name
Novin Nikbakhsh
Name of organization / entity
Babol University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 11 3225 6285
Email address
n.nicbakhsh@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol University of Medical Sciences
Expected recruitment start date
2013-11-22, 1392/09/01
Expected recruitment end date
2014-11-22, 1393/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Single dose versus triple dose of antibiotic in prophylaxis of wound infection in acute appendicitis: prospective randomized study
Public title
Single dose versus triple dose of antibiotic in prophylaxis of wound infection in acute appendicitis: prospective randomized study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with acute suppurative appendicitis are pleased to participate in the study
Exclusion criteria: Patients with a normal appendix; gangrenous; perforated; a patient endocarditis
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Babol University of Medical Sciences
Street address
Babol University of Medical Sciences,University Square,Babol
City
Babol
Postal code
Approval date
2013-11-09, 1392/08/18
Ethics committee reference number
3326
Health conditions studied
1
Description of health condition studied
surgical infection
ICD-10 code
O75.4
ICD-10 code description
Other complications of obstetric surgery and procedures
Primary outcomes
1
Description
Infection
Timepoint
One month
Method of measurement
Clinical
Secondary outcomes
1
Description
Fever and chills
Timepoint
24 hours after surgery
Method of measurement
Clinical
Intervention groups
1
Description
The intervention group received diet antibiotic metronidazole 500 mg single dose and one gram of ceftriaxone intravenously before surgery
Category
Treatment - Drugs
2
Description
Under the control of antibiotic metronidazole 500 mg single dose or two doses of one gram of ceftriaxone intravenously before surgery and after surgery (continuing until 24 hours after surgery) as well
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Babol Shahid Beheshti Hospital
Full name of responsible person
Street address
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Full name of responsible person
Aliakbar Moghaddamnia
Street address
Babol University of Medical Sciences, University Square,Babol
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology, Babol 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Novin Nikbakhsh
Position
Associate Professer of Surgery
Other areas of specialty/work
Street address
Shahid Beheshi Hospital, Keshvari Square, Babol
City
Babol
Postal code
Phone
+1 132256285
Fax
Email
novinsu@hotmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)