Clinical trials of surgical site with disinfectant spray Chlorhexidine-Alcohol compared to those who received Povidone-Iodine to reduce the amount of infection in surgery.
Objectives: Due to limited studies in this regard, especially the cultivation of the surgical site after surgery has been done. We decide to check and compare disinfect the skin with Povidone-Iodine and Chlorhexidine-Alcohol surgery in patients undergoing non-emergency surgery in the Baqiyatallah hospital too.
Design: This is a triple-blind, randomized clinical trial.
Setting and conduct: This study will perform at the Baqiyatallah University of Medical Sciences. In this study, the patients, measuring the outcomes of study participants (researchers) or Data Monitoring Committee (analyzers) of the patients unaware about intervention. Hospital patients undergoing elective abdominal surgery (clean-contaminated) were put into the project. Clean-contaminated surgery, including elective cholecystectomy and operation of the digestive system that includes a variety of Gastrostomy, resection of the small intestine, are the colectomy. Patients in both groups will divide randomly using a table of random numbers. Count of Bacteria is another outcome in this study and assess using the laboratory. This clinical trial is a phase 2 study.
Major Inclusion and Exclusion criteria: All patients who do not follow. Patients who will died during this study. Clear immunocompromised patients (transplant patients and AIDS), chronic skin disease, radiation therapy and chronic inflammatory disease.
Intervention: 100 patients with Povidone-Iodine and 100 people using Chlorhexidine antiseptic alcohol will evaluate.
Main outcome measures (variables): The main outcome of this study is the infection and numbers of Bacteria.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015110724706N1
Registration date:2016-05-02, 1395/02/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-02, 1395/02/13
Registrant information
Name
Reza Mirnejad
Name of organization / entity
Baqiyatallah university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8248 2398
Email address
rmirnejad@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Baqiyatallah University of Medical Sciences
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trials of surgical site with disinfectant spray Chlorhexidine-Alcohol compared to those who received Povidone-Iodine to reduce the amount of infection in surgery.
Public title
Comparison of the results and complication of the two methods Chlorhexidine–Alcohol and Povidone–Iodine in non-emergency abdominal surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Hospital patients undergoing elective abdominal surgery (clean-contaminated) were put into the project.
Exclusion criteria: All patients who do not follow. Patients who died during this study; Clear immunocompromised patients (transplant patients and AIDS), chronic skin disease; radiation therapy and chronic inflammatory disease; All patients who do not follow; Patients who died during this study.
Age
From 20 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Baqiyatallah University of Medical Sciences
Street address
Postal code: 1435917541, Mollasadra, St - Sheikh Bahaee, St, Tehran
City
Tehran
Postal code
1435917541
Approval date
2014-09-23, 1393/07/01
Ethics committee reference number
ir.bmsu.rec.94.51
Health conditions studied
1
Description of health condition studied
Infection abdominal postoperative
ICD-10 code
T81.5
ICD-10 code description
Foreign body accidentally left in body cavity or operation wound following a procedure
Primary outcomes
1
Description
Infection
Timepoint
One and two weeks after operation
Method of measurement
Medical evaluation
Secondary outcomes
1
Description
The number of bacteria grown
Timepoint
One and two weeks after operation
Method of measurement
Laboratory
Intervention groups
1
Description
Intervention 2: Povidone–Iodine (Betadin), 10 milliliters once before surgery, Povidone–Iodine is a stable chemical complex of Polyvinylpyrrolidone (Povidone, PVP) and elemental iodine. It contains from 9.0% to 12.0% available iodine, calculated on a dry basis. Brand of Penthrox is Methoxyflurane. Brand of Povidone–Iodine is Betadin. Povidone-iodine applied to an abrasion using a cotton swab.
Category
Prevention
2
Description
Intervention 1: Spray disinfectant Chlorhexidine-alcohol, 10 milliliters once before surgery, Chlorhexidine-Alcohol based chlorhexidine Gluconate and 70% isopropyl alcohol 2% D is formulated. How to use: Chlorhexidine-alcohol solutions in areas of the skin spray and wait for 30 minutes to dry. Brand of Chlorhexidine-Alcohol is Badi Prop.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Surgery Department of Baqiyatallah hospital
Full name of responsible person
Moharam Mohammadian
Street address
Postal code: 1435917541, Mollasadra Street, Sheikh Bahaee St, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Baqiyatallah University of Medical Sciences
Full name of responsible person
Hamid Reza Rasouli
Street address
Postal code: 1435917541, Mollasadra Street, Sheikh Bahaee Street, Tehran
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, Baqiyatallah 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
Baqiyatallah University of Medical Sciences
Full name of responsible person
Ali Ebrahimi
Position
Faculty member, Plastic surgery
Other areas of specialty/work
Street address
Mollasadra Street, Sheikh Bahaee Street, Tehran
City
Tehran
Postal code
Postal code: 1435917
Phone
+98 21 8805 3766
Fax
Email
ae_49341@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Ali Ebrahimi
Position
Plastic surgery
Other areas of specialty/work
Street address
Postal code: 1435917541, Mollasadra Street, Sheikh Bahaee Street, Tehran
City
Tehran
Postal code
1435917541
Phone
+98 21 8805 3766
Fax
Email
ae_49341@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Moharam Mohammadian
Position
Assistant of general surgery
Other areas of specialty/work
Street address
Mollasadra St, Sheikh Bahaee St, Tehran
City
Tehran
Postal code
1435917541
Phone
+98 21 8805 3766
Fax
Email
dr_m.mohammadian@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)