comparison of efficacy of two treatment regimen,cefazolin alone with cefazolin plus metronidazol in the prevention of surgical site infections after hysterectomy
Effect of intravenous cefazolin alone in comparison with cefazolin plus metronidazole in preventing surgical site infections after hysterectomy
Design
A clinical trial with intervention and control group with a sample size of 400 cases, with parallel group, double-blind, randomized clinical trial phase 2-3 during four months of evaluation
Settings and conduct
This randomized double-blind clinical trial is performed on patients undergoing hysterectomy referred to Ayatollah Rouhani Hospital of Babol University of Medical Sciences. In this study, physicians and patients are not aware of the chosen treatment protocol.
Participants/Inclusion and exclusion criteria
All patients undergoing hysterectomy are included in the study.
Exclusion criteria in this study included patients with blood disorders (thrombocytopenia), cardiovascular disorders, hepatic disorders with more than 15 seconds of prothrombin time, uncontrolled diabetes and hypertension and any uncontrolled underlying disease that worsened following anesthesia.
Intervention groups
The control group consisted of patients undergoing hysterectomy prophylactic with cefazolin, and the intervention group included patients undergoing hysterectomy prophylactic with cefazolin and metronidazole suppository.
Main outcome variables
postoperative infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200128046289N1
Registration date:2020-02-22, 1398/12/03
Registration timing:registered_while_recruiting
Last update:2020-02-22, 1398/12/03
Update count:0
Registration date
2020-02-22, 1398/12/03
Registrant information
Name
Masomeh Bayani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3223 8284
Email address
m.baiany@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-04, 1398/11/15
Expected recruitment end date
2020-05-21, 1399/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of efficacy of two treatment regimen,cefazolin alone with cefazolin plus metronidazol in the prevention of surgical site infections after hysterectomy
Public title
comparison of efficacy of two treatment regimen,cefazolin alone with cefazolin plus metronidazol in the prevention of surgical site infections after hysterectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All women who are candidates for hysterectomy
Exclusion criteria:
Sensitivities to cefazolin
Sensitivities to metronidazole
sensitivities to penicillins
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
400
Randomization (investigator's opinion)
Randomized
Randomization description
After obtaining informed consent from the patients, they were coded by random numbers that came out of the envelope and patients were divided into control and intervention groups. Then the treatment protocol is performed by the nurse and midwife for both groups.
The treatment protocol in this study is as follows:
Standard method: Two grams of intravenous cefazolin for the first group (as control group) one hour before surgery and two grams of intravenous cefazolin plus 500 mg metronidazole suppository one hour before surgery in the second group (intervention group).
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, random numbers coded by the head-nurse and midwife are extracted from a pre-prepared envelope by the researcher. Then patients are divided into two groups: control and intervention. Research protocol of the study is performed by the head-nurse and midwife for both groups. The physician and patients are not aware of the chosen treatment protocol.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Babol University of Medical Sciences
Street address
Ganjafrooz Ave, Babol, Mazandaran, Iran
City
BABOL
Province
Mazandaran
Postal code
4717647745
Approval date
2019-01-20, 1397/10/30
Ethics committee reference number
IR.MUBABOL.HRI.REC.1397.262
Health conditions studied
1
Description of health condition studied
Skin Site Infection after Hysterectomy
ICD-10 code
T81.4
ICD-10 code description
Infection following a procedure
Primary outcomes
1
Description
Postoperative infection
Timepoint
Twelve months
Method of measurement
Based on ICD-10 Code criteria description
Secondary outcomes
1
Description
Prevention of infection after hysterectomy
Timepoint
Thirty days after the hysterectomy
Method of measurement
Clinical signs of wound infection (redness, swelling, warmth, discharge)
Intervention groups
1
Description
Patients who are candidate for hysterectomy receiving Cefazolin 2gr IV one hour before surgery alone as control group.
Category
Prevention
2
Description
Patients who are candidate for hysterectomy receiving Cefazolin 2gr IV plus Metronidazole 500 mg IV one hour before surgery as intervention group.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Rohani hospital
Full name of responsible person
Masomeh Bayani
Street address
Ganjafrooz Ave, Babol, Mazandaran, Iran
City
BABOL
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3223 8284
Fax
+98 11 3223 8284
Email
m_baiany@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Ganjafrooz Ave, Babol, Mazandaran, Iran
City
BABOL
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 2832
Fax
+98 11 3219 2959
Email
rezaghadimi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Masomeh Bayani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Ganjafrooz Ave,
City
BABOL
Province
Mazandaran
Postal code
۴۷۱۷۶۴۷۷۴۵
Phone
009832238284
Fax
Email
m_baiany@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Masomeh Bayani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Ganjafrooz Ave, Babol, Mazandaran, Iran
City
BABOL
Province
Mazandaran
Postal code
۴۷۱۷۶۴۷۷۴۵
Phone
00981132199592-6
Email
m_baiany@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Masomeh Bayani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Ganjafrooz Ave, Babol, Mazandaran, Iran
City
BABOL
Province
Mazandaran
Postal code
۴۷۱۷۶۴۷۷۴۵
Phone
009832238301
Email
m_bayani@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available