(1) Objectives; The aim of this study is the role of postoperative antibiotics in prevention of infection in open reduction of mandibular compound fractures. (2) Design; This study is a Randomized, double blind, placebo controlled clinical trial. (3) Setting and conduct; 80 Patients diagnosed with open fractures of the mandible were placed on two groups: Antibiotic group or non antibiotic group and they receive 2-5 day preoperatively 1gr Cefazolin IV qid. Antibiotics 1gr Cefazolin IV was continued for 30 minutes before surgery. At the time of the surgery all the patients received intraoperative antibiotics which consisted of Cefazolin IV 1gr (900 mg clindamycin IV if allergic to penicillin). At the conclusion if the procedure is going to take more than 5 hours the patients would receive 1gr Cefazolin IV. At the end of the surgery the patients were randomized into 2 groups (antibiotic group and non antibiotic group). (4) Participants including major eligibility criteria; The main inclusion criteria consists of at least 1 fracture of mandible and open reduction and internal fixation. Exclusion criteria are presence of an acute bacterial infection, fracture of the skull base and Inter Maxillary Fixation. (5) Intervention; The antibiotic group receive 600mg Clindamycin IV tds 7 days postoperative with chlorhexidine gluconate 0.12% oral rinse. The drug company is Dana Tabriz, Iran. The non antibiotic group receive placebo drug for 7 days with chlorhexidine gluconate 0.12% oral rinse. (6) main outcome measures; Patients were examined at 1, 3 and 5 weeks for signs and symptoms of infection using the following clinical criteria: Infection, Erythema, Drainage, Fever.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015041521787N1
Registration date:2015-09-14, 1394/06/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-09-14, 1394/06/23
Registrant information
Name
Minou Najarnobari
Name of organization / entity
Tehran university of medical science, dental school
Country
Iran (Islamic Republic of)
Phone
+98 21 6693 1225
Email address
m-nobari@student.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2015-09-11, 1394/06/20
Expected recruitment end date
2016-09-10, 1395/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The role of postoperative antibiotics in prevention of infection at open reduction of mandibular compound fractures
Public title
The role of antibiotics in mandibular fractures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Open reduction and internal fixation; At least 1 fracture of mandible; Follow up of at least 5 weeks.
Exclusion criteria: Infection during surgry; Gunshot wounds; Need for intensive care; Presence of an acute bacterial infection; Pathological fractures; Fracture of the skull base; History of malignancy/ radiation of the head and neck area; Immunosuppression; Reduced body weight; Kidney disease; Inter Maxillary Fixation; Insufficient follow up
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
75
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
Ethics committee of Tehran university of medical science
Street address
Ghods central building, Ghods street, Keshavarz street, Tehran, Iran
City
Tehran
Postal code
Approval date
2015-06-16, 1394/03/26
Ethics committee reference number
IR.TUMS.REC.1394.54
Health conditions studied
1
Description of health condition studied
Mandibular fracture
ICD-10 code
S02.6
ICD-10 code description
Lower jaw (bone)
Primary outcomes
1
Description
Infection
Timepoint
Follow up appointments were 1,3,5 weeks postoperatively
Patients diagnosed with open fractures of the mandible were placed on two groups: Antibiotic group or non antibiotic group and they receive 2-5 day preoperatively 1gr Cefazolin IV qid. Antibiotics 1gr Cefazolin IV were continued for 30 minutes before surgery. At the time of the surgery all the patients received intraoperative antibiotics which consisted of Cefazolin IV 1gr (900 mg clindamycin IV if allergic to penicillin). At the conclusion if the procedure is going to take more than 5 hours the patients would receive 1gr Cefazolin IV. At the end of the surgery the patients were randomized into 2 groups ( antibiotic group and non antibiotic group). The antibiotic group receive 600mg Clindamycin IV tds 7 days postoperative with chlorhexidine gluconate 0.12% oral rinse. The drug company is Dana Tabriz, Iran.
Category
Treatment - Drugs
2
Description
Patients diagnosed with open fractures of the mandible were placed on two groups: Antibiotic group or non antibiotic group and they receive 2-5 day preoperatively 1gr Cefazolin IV qid. Antibiotics 1gr Cefazolin IV were continued for 30 minutes before surgery. At the time of the surgery all the patients received intraoperative antibiotics which consisted of Cefazolin IV 1gr (900 mg clindamycin IV if allergic to penicillin). At the conclusion if the procedure is going to take more than 5 hours the patients would receive 1gr Cefazolin IV. At the end of the surgery the patients were randomized into 2 groups ( antibiotic group and non antibiotic group). The non Ab group receive placebo drug for 7 days with chlorhexidine gluconate 0.12% oral rinse.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr Shariati hospital
Full name of responsible person
Dr Mehrnoush Momeni Rouchi
Street address
Dr Shariati hospital, Nasr bridge, Kargar street, Tehran, Iran
City
Tehran
2
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Dr Mehrnoush Momeni Rouchi
Street address
Sina hospital, Hassan Abad street, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr Amirreza Rokn
Street address
Tehran Dentistry school, kargar street, Hakim street, Tehran, Iran
City
Tehran
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, Tehran 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
Tehran university of medical science
Full name of responsible person
Dr. Mehrnoush Momeni Rouchi
Position
DDS; MDS
Other areas of specialty/work
Street address
Dental School of Tehran university of medical science, Hakim street, Kargar street, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8835 1150
Fax
Email
m-nobari@student.tums.ac.ir ; minnobari@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran university of medical science
Full name of responsible person
Dr. Mehrnoush Momeni Rouchi
Position
DDS ; MDS
Other areas of specialty/work
Street address
Tehran university of medical science, Hakim street, Kargar street, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8835 1150
Fax
Email
m-nobari@student.tums.ac.ir ; minnobari@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dental school of Tehran university of medical science
Full name of responsible person
Minou Najarnobari
Position
Student at dental school of Tehran university of medical science
Other areas of specialty/work
Street address
Dental school, Kargar street, Hakim street, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8835 1150
Fax
Email
m-nobari@student.tums.ac.ir ; minnobari@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)