Can Prophylactic Postoperative Oral Antibiotic Cause Methicillin Resistant Staphylococcus aureus species in Septoplasty or Rhinoplasty?
Design
In a double-blind randomized clinical trial 102 patients who were candidates for septoplasty or rhinoplasty were divided into itntervention and control groups. The intervention group received a preoperative injection of cephalothin (1 g) and postoperative oral cephalexin (500 mg 4 times a day for 7 days). The control group only received preoperative injection of cephalothin (1g). In studied patients, vestibular nasal swab were cultured preoperatively and on 7th postoperative day. Then, the samples were transferred quickly to the laboratory to detect methicillin resistant staphylococcus aureus species.
Settings and conduct
In a double-blind randomized clinical trial 102 patients who were candidates for septoplasty or rhinoplasty were divided into itwo ntervention and control groups. The intervention group received a preoperative injection of cephalothin (1 g) and postoperative oral cephalexin (500 mg 4 times a day for 7 days).The control group only received preoperative injection of cephalothin (1g).
Participants/Inclusion and exclusion criteria
Exclusion criteria: patients with any type of immune deficiencies; upper respiratory infection; any history of antibiotic usage in last 3 months; any hospital admission during last year; any history of allergic reaction to cephalexin
Inclusion criteria: Patients known to be at risk for Methicillin resistant Staphylococcus aureus species colonization and infection after rhinoplasty.
Intervention groups
The control group only received preoperative injection of cephalothin (1g). The case group received a preoperative injection of cephalothin (1 g) and postoperative oral cephalexin (500 mg 4 times a day for 7 days).
Main outcome variables
Methicillin resistant staphylococcus aureus species
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140618018143N4
Registration date:2018-12-09, 1397/09/18
Registration timing:retrospective
Last update:2018-12-09, 1397/09/18
Update count:0
Registration date
2018-12-09, 1397/09/18
Registrant information
Name
nader akbari dilmaghani
Name of organization / entity
shahid beheshti medical university
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 9005
Email address
nadakbari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2014-08-30, 1393/06/08
Actual recruitment start date
2013-06-22, 1392/04/01
Actual recruitment end date
2014-08-30, 1393/06/08
Trial completion date
2014-08-30, 1393/06/08
Scientific title
Can Prophylactic Postoperative Oral Antibiotic Cause Methicillin Resistant Staphylococcus aureus species (MRSA) in Septoplasty or Rhinoplasty?
Public title
Methicillin Resistant Staphylococcus aureus species in Septoplasty or Rhinoplasty
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients known to be at risk for Methicillin Resistant Staphylococcus aureus species colonization and infection after surgery
Exclusion criteria:
Age older than 60 years old
HIV
Those with recent hospital admission
Those with recent antibiotic use
Immunodeficiency
Upper respiratory infection
Age
To 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
102
Actual sample size reached:
98
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
ُSurgeon and the patients were blind to the groups' allocation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Yaman
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2013-04-26, 1392/02/06
Ethics committee reference number
SBMU.REC.1392.26
Health conditions studied
1
Description of health condition studied
Septoplasty or Rhinoplasty
ICD-10 code
J00
ICD-10 code description
Acute nasopharyngitis [common cold]
Primary outcomes
1
Description
Detection of methicillin resistant staphylococcus aureus species
Timepoint
Preoperative and on 7th day postoperative
Method of measurement
The samples were cultured onto a mannitol salt agar medium for isolation of S. aureus and then incubated at 35°C overnight. The isolated bacteria were identified based on morphologic and biochemical tests. Isolated staphylococcus aureus were screened for methicillin-resistance.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group received a preoperative injection of cephalothin (1 g) and postoperative oral cephalexin (500 mg 4 times a day for 7 days).
Category
Treatment - Drugs
2
Description
Control group: The control group only received preoperative injection of cephalothin (1g).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman Hakim Hospital
Full name of responsible person
Nader Akbari Dilmaghani
Street address
Loghman Hakim Hospital, Makhsus St, Lashkar Crossload, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
nadakbari@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Ali Ziaee
Street address
Deputy of Research Center, Shahid Besheshti University, Shahid Abbas Erabi St. Yamn St. Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9781
Email
mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
2
Sponsor
Name of organization / entity
معاونت پژوهشی دانشگاه علوم پزشکی شهید بهشتی
Full name of responsible person
Nader Akbari Deilamghani
Street address
Loghman Hakim Hospital, Makhsus St, Lashkar Crossload,Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
nadakbari@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
معاونت پژوهشی دانشگاه علوم پزشکی شهید بهشتی
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nader Akbari Dilmaghani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Loghman Hakim Hospital, Makhsus St, Lashkar Crossroad, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
nadakbari@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nader Akbari Dilmaghani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Loghman Hakim Hospital, Makhsus St, Lashkar Crossload, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
nadakbari@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shima Arastou
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Loghman Hakim Hospital, Makhsus St, Lashkar Crossload, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
arastoo_shima@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Some parts of data related to main result can be shared.
When the data will become available and for how long
After published
To whom data/document is available
Academic Researchers
Under which criteria data/document could be used
Clinicians
From where data/document is obtainable
Email
What processes are involved for a request to access data/document