Comparison of wound irrigation with 1% Povidone Iodine solution and normal saline on wound infection rate of patients with simple traumatic wound; A randomized clinical trial
Objectives: Prevention of wound infection is one of the most important tasks during wound management in emergency departments.Design: This is a non-blind, interventional, randomized clinical trial. Setting: This study will be conducted in 2 academic emergency department with 100000 overall annual census. Participants: All patients older than 18 years and simple traumatic wound would be approached. Those with comorbid disease such as diabetes, cirrhosis or renal failure, those on antibiotics, steroids, immunosuppressive drugs and immunodeficient patients, those with injuries to bone and joint and other organs will be excluded.Interventions: Then they will assign to intervention and control group. In intervention group wounds will be irrigated with 50 milliliter per centimeter (ml/cm) of 1% Povidone Iodine solution and in control group wounds will be irrigated with 50 ml/cm of normal saline solution. Main outcome measures: They will revisit for wound check and any sign of wound infection and skin irritation in 2nd, 5th and 10th days after wound repair for any sign of wound infection. A telephone follow up will be scheduled for one month later.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201501038104N11
Registration date:2015-01-25, 1393/11/05
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-01-25, 1393/11/05
Registrant information
Name
Mohammad Amin Zare
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6652 5327
Email address
ma-zare@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2015-01-30, 1393/11/10
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of wound irrigation with 1% Povidone Iodine solution and normal saline on wound infection rate of patients with simple traumatic wound; A randomized clinical trial
Public title
Povidone Iodine and wound infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
Simple Traumatic Wound; Age over 18 years old
Exclusion Criteria:
Human or Animal bite; Tendon, nerve or vessel involvement; More than 12 hours since trauma; Concomitant joint or bone injuries; Any other traumatic injury to other organs; Bullet or high energy shrapnel wounds; Those on Antibiotics, Immunosuppressive drugs or steroids before trauma; Cirrhosis, Chronic Renal failure, Diabetes; Acquired or congenital immune compromised patients; Prosthetic heart valve; Allergy to Iodine; Chronic substance or alcohol abuse
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
350
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences' Ethics comittee
Street address
Hemmat Highway, Cross with Sheikh Fazlollah Highway
City
Tehran
Postal code
Approval date
2014-12-17, 1393/09/26
Ethics committee reference number
93/d/105/4547
Health conditions studied
1
Description of health condition studied
Wound
ICD-10 code
XIX
ICD-10 code description
Injury, poisoning and certain other consequences of external causes
Primary outcomes
1
Description
Wound infection
Timepoint
2, 5, 10 and 30 days after procedure
Method of measurement
Direct observation in days 2, 5 and 10 and telephone follow up 30 days after procedure
Secondary outcomes
1
Description
wound dehicense and skin irritation
Timepoint
2, 5, 10 and 30 days after procedure
Method of measurement
Direct observation in days 2, 5, 10 after procedure and telephone follow up in day 30
Intervention groups
1
Description
Intervention:
Irrigation of wound with 50 ml/cm of wound length with 1% Povidone Iodine solution
Category
Treatment - Drugs
2
Description
Control
Irrigation of wound with 50 ml/cm of wound lenght with normal saline solution
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram Hospital
Full name of responsible person
Marzieh Fathi
Street address
Niyayesh St, Sattarkhan Ave
City
Tehran
2
Recruitment center
Name of recruitment center
7th of Tir Martyres Hospital
Full name of responsible person
Mina Zavareh
Street address
Shahid Radjayi Blvd.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences Vice Chancellor of Research
Full name of responsible person
Seyyed Ali Javad Mousavi
Street address
Hemmat Highway, Cross with Sheikh Fazlollah Hwy
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences Vice Chancellor of Research
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
Iran University of Medical Sciences
Full name of responsible person
Mina Zavareh
Position
MD
Other areas of specialty/work
Street address
Niyayesh St, Sattarkhan Ave
City
Tehran
Postal code
Phone
+98 21 6652 5327
Fax
Email
mina_zavareh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical SCiences
Full name of responsible person
Marzieh Fathi
Position
Assistant Professor
Other areas of specialty/work
Street address
Niyayesh St, Sattarkhan Ave
City
Tehran
Postal code
Phone
+98 21 6652 5327
Fax
Email
marziehfathi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical SCiences
Full name of responsible person
Marzieh Fathi
Position
Assistant Professor
Other areas of specialty/work
Street address
Niyayesh St, Sattarkhan Ave
City
Tehran
Postal code
Phone
+98 21 6652 5327
Fax
Email
marziehfathi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)