Comparison of effectiveness of oral antibiotic with intravenous antibiotic in prophylaxis of wound infection in patients with hand laceration who come to emergency department
Aims: Evaluation of effectiveness of oral antibiotic with intravenous antibiotic in prevention of wound infection in patient with hand laceration.
Inclusion and exclusion criteria:Inclusion Criteria consist of
patients consent to participation in the study and patients with class 2 hand laceration , exclusion criteria consist of unwillingness to study participation and admission to hospital wards due to any risen.
Study population: All patients with hand laceration who come to emergency wards of Shariati and Sina Hospital during the recruitment period.
Sample size: According to analysis the total sample size in both groups are 746 patients.
Intervention: In first group patients receive intravenous cefazolin per KG of body weight before procedure and then discharged home with oral cephalexin for 48 hours. In second group, patients receive oral cephalexin per KG of body weight before procedure and then discharged home with oral cephalexin for 48 hours.Triage nurse gives drugs to patients randomly according to study groups. patients, physicians and statistics specialist are blind to data and administered drugs in the whole of the study. In cefazolin group patients receive an oral placebo similar to cephalexin capsules and in oral cephalexin patients receive normal saline as a placebo.
Primary outcomes: All patients evaluate after 48 hours for sign of wound infection such as erythema, swelling and secretion.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201707118872N12
Registration date:2017-07-23, 1396/05/01
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-07-23, 1396/05/01
Registrant information
Name
Morteza Saeedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2719
Email address
m_saeedi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research deputy of medicine faculty of Tehran University of Medical Sciences
Expected recruitment start date
2017-07-27, 1396/05/05
Expected recruitment end date
2018-01-25, 1396/11/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effectiveness of oral antibiotic with intravenous antibiotic in prophylaxis of wound infection in patients with hand laceration who come to emergency department
Public title
oral antibiotic effectiveness in prevention of wound infection in hand laceration
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
patients consent to participation in the study; patients with class 2 hand laceration whom treated by emergency physicians.
Exclusion Criteria:
patients with crash laceration; hand laceration accompanied by tendon injury that mandate patient admission; open fractures; bite wound; patient needed to admission to other services; laceration which needed to repair in operating room; allergic history to cephalosporins.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
764
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Siences
Street address
floor 5, NO 226,Poursina avenue, Ghods avenue,Enghelab square, Tehran
City
Tehran
Postal code
Approval date
2016-10-04, 1395/07/13
Ethics committee reference number
IR.TUMS.REC.2845
Health conditions studied
1
Description of health condition studied
hand laceration
ICD-10 code
s61.9
ICD-10 code description
Open wound of wrist and hand part, part unspecified
Primary outcomes
1
Description
prevalence of wound infection
Timepoint
48 hours after wound repair
Method of measurement
observation
Secondary outcomes
empty
Intervention groups
1
Description
In intervention group, patients receive oral cephalexin per KG of body weight before procedure and receive normal saline as a placebo then discharged home with oral cephalexin for 48 hours.
Category
Treatment - Drugs
2
Description
In control group patients receive intravenous cefazolin per KG of body weight before procedure and patients receive an oral placebo similar to cephalexin capsules then discharged home with oral cephalexin for 48 hours.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emergency Department of Sina and Shariati Hospitals
Full name of responsible person
Morteza Saeedi
Street address
Sina Hospital ( Hsanabad Square)and Shariati Hospital(beside Eghtesad university; Al Ahmad high way; North Kargar avenue) Emergency Departement
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences -Faculty of Medicine
Full name of responsible person
Shahin Akhondzadeh Basti
Street address
Building No 1, North entrance door of Tehran University, Poursina sreet, Qods street, Enghelab street
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 -Faculty of Medicine
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
Full name of responsible person
Morteza Saeedi
Position
Associate professor/ Emergency Medicine specialist
Other areas of specialty/work
Street address
Shariati Hospital, North Amirabad street
City
Tehran
Postal code
1411713135
Phone
+98 21 8490 2717
Fax
Email
m_saeedi@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Morteza Saeedi
Position
Associate professor/ Emergency Medicine specialist
Other areas of specialty/work
Street address
Shariati Hospital, North Amirabad street
City
Tehran
Postal code
Phone
+98 21 8490 2717
Fax
Email
m_saeedi@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Morteza Saeedi
Position
Associate professor/ Emergency Medicine specialist
Other areas of specialty/work
Street address
Shariati Hospital, North Amirabad street
City
Tehran
Postal code
1411713135
Phone
+98 21 8490 2717
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)