Use of clean nonsterile gloves versus sterile gloves in contaminated simple traumatic wounds repair in ED can reduce treatment costs significantly .For this purpose in this trial we will compare post operative infection rate in two randomized repaired contaminated simple wounds groups with sterile & nonsterile clean gloves in emergency department of 7th tir hospitals during 22/11/2010 to 22/7/2011.Our 200 desired cases include all simple traumatic contaminated wounds with indication of antibiotic prophylaxis & exclusion criteria and without age limitation. They will be selected in a convenience sampling and will be divided into two equal groups using table of random numbers .In one group we will suture the simple contaminated traumatic wounds with sterile gloves and in other group use clean nonsterile gloves .For both groups oral prophylactic antibiotic will be prescribed at the same regimen for 5 days. Within following ten days, patients will be asked through phone about the infection symptoms(redness ,inflammation ,warmth ,pus discharge,fever).After reaching the desired number of cases we will analyze data with SPSS software to discerning is it meaningful differences in infection between two groups. All infected wounds will be followed at the hospital emergency clinic.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201011175193N1
Registration date:2011-02-05, 1389/11/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-02-05, 1389/11/16
Registrant information
Name
Shafea jafar Zoofaghari
Name of organization / entity
Tehran University Of Medical Science & Health Services
Country
Iran (Islamic Republic of)
Phone
+98 21 5522 8573
Email address
hbgssl@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University Of Medical Science & Health Services
Expected recruitment start date
2010-11-22, 1389/09/01
Expected recruitment end date
2011-07-23, 1390/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of infection rate for sterile vs unsterile but clean gloves in repairing of contaminated simple traumatic wounds in emergency department
Public title
Outcome of clean unsterile gloves in post repaired wounds infection rate
Purpose
Treatment
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
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
no
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Science & Health Services
Street address
Crossroad of Hemmat & Fazl-allah Expway
City
Tehran
Postal code
Approval date
2010-10-10, 1389/07/18
Ethics committee reference number
7/895
Health conditions studied
1
Description of health condition studied
Traumatic simple and cotaminated wounds of body
ICD-10 code
S00, T98
ICD-10 code description
Injury, poisoning and certain other consequences of external causes
Primary outcomes
1
Description
Infection rate
Timepoint
for 10 days after repair
Method of measurement
Asking about infection symptoms by phone (redness, inflammation, warmth, pus discharge, fever)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: use of clean unsterile gloves
Category
Treatment - Devices
2
Description
Control: use of sterile gloves
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
7th tir Hospital
Full name of responsible person
Dr. Shafea Jafar Zoofaghari
Street address
7th Hospital, Rajaee St. Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University Of Medical Sciences & Health Services
Full name of responsible person
Research Commitee
Street address
Crossroad of Hemmat & Fazl-allah Expway
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 & Health Services
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 & Health Services
Full name of responsible person
Shafea Jafar Zoofaghari
Position
Emergency Medicine Resident
Other areas of specialty/work
Street address
Rasooleakram Hospital, Sttarkhan St.
City
Tehran
Postal code
8199934388
Phone
00983112302940-00982166525327
Fax
Email
sh.zf9438@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University Of Medical Science & Health Services
Full name of responsible person
Hamed Basir Ghafoori
Position
Emergency Medicine Specialist
Other areas of specialty/work
Street address
Rasooleakram Hospital
City
Tehran
Postal code
Phone
+98 21 6652 5327
Fax
Email
hbgssl@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University Of Medical Sciences & Health Services
Full name of responsible person
Shafea Jafar Zoofaghari
Position
Emergency Medicine Resident
Other areas of specialty/work
Street address
Rasooleakram Hospital- Sattarkhan St.
City
Tehran
Postal code
8199934388
Phone
00983112302940-00982166525327
Fax
Email
sh.zf9438@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)