It has been proven that limited use of antibiotics for infection prophylaxis in simple dirty wounds is quite useful and reasonable, especially when the wounds are closed primarily at emergency department. Cephalexin has been used for this purpose for decades. we are going to find another proper antibiotic regimen to replace it. Patients over 16 who are admitted to emergency department of Rasoul akram and Sina Hospital because of simple dirty wounds not obtaining any of exclusion criteria and their wound would undergone primary closure at emergency room will be randomly divided to two groups; one receiving 3 days regimen of Cephalexin ( 1gr before wound manipulation and 500mg QID for 3 days), and the other will get Azithromycin (500mg before wound manipulation and then 250mg daily). All patients will be visited after 48 hours of wound closure and at the time of sutures removal between 7 to 10 days, in addition to that all patients will be informed of infection signs and symptoms and would be asked to contact the researcher for observing the wound and treating the infection. by the end of study the incidence of infection in two groups will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012071810017N3
Registration date:2012-07-24, 1391/05/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-07-24, 1391/05/03
Registrant information
Name
Hamed Basir Ghafouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6653 9233
Email address
h-basirghafouri@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University Of Medical Sciences,Tehran,Iran.
Expected recruitment start date
2012-04-03, 1391/01/15
Expected recruitment end date
2012-08-05, 1391/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Cephalexin and Azithromycin regimen for infection prophylaxis in simple dirty wounds treated at emergency department.
Public title
effect of azithromycin on the prevention of wound infection
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: presence of traumatic simple wounds with indication of antibiotic prophylaxis according to responsible physician’s opinion
Exclusion criteria: presence of penetrating wound, longer than 12 hours, presence of diabetes, cirrhosis, or renal failure, current using of antibiotics or immunosuppressive agents, splenectomy, prosthetics heart valves, immunosuppressive disorders, fractures at the site of wound, bites, joint, neurovascular or tendon involvement
Age
From 16 years old to 149 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
400
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
Tehran Universty of Medical Sciences Ethics Committee
Street address
Keshavarz Blvd, Qods St. Headquarter for Tehran University of Medical Sciences,
City
Tehran
Postal code
Approval date
2012-03-29, 1391/01/10
Ethics committee reference number
130/2649/د/90
Health conditions studied
1
Description of health condition studied
traumatic wounds management
ICD-10 code
T79.3
ICD-10 code description
Post-traumatic wound infection, not elsewhere classified
Primary outcomes
1
Description
infection
Timepoint
48 hr,240 hr
Method of measurement
presence of either a stitch abscess, cellulitis greater than 1 cm,or purulent drainage
Secondary outcomes
empty
Intervention groups
1
Description
control:oral cephalexin 1000 mg befor wound manipulation and then 500 mg q 6 h for 3 days
Category
Treatment - Drugs
2
Description
intervention:oral azithromycin 500 mg befor manipulation and then 250 mg daily for 3 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Hamed Basir Ghafouri
Street address
Hasan abad sq., Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Shahin Akhundzadeh
Street address
Keshavarz Blvd. Pour Sna street.Tehran University of Medical Siences, School of Medicine .first floor .No303
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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 Sciences, School of Medicine