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Comparison of prophylactic antibiotic and immunostimulant in preventing wound infection and abases after abdominal surgery.

Protocol summary

Study aim
Comparison of the effect of prophylactic antibiotics and prophylactic antibiotics with golden immunostimulant in the prevention of postoperative cannelloni ulcers.
Design
60 patients who underwent abdominal surgery in the Vali-e-Asr Hospital during surgery were randomly and completely randomly selected from both males and females with informed consent of the patients and divided into two equal groups. The intervention group will receive a prophylaxis antibiotic with or without oral immunostimulants, orally, three times a day, one capsule, for 10 days. All patients are examined for signs of infection, inflammation, hematoma, and ulcers and serum openings when hospital discharge. In the control group, no immunostimulant is used.
Settings and conduct
60 patients who underwent abdominal surgery in the Vali-e-Asr Hospital during surgery were randomly and completely randomly selected from both males and females with informed consent of the patients and divided into two equal groups. The intervention group will receive a prophylaxis antibiotic with or without oral immunostimulants, orally, three times a day, one capsule, for 10 days. All patients are examined for signs of infection, inflammation, hematoma, and ulcers and serum openings before being hospitalized. In the control group, no immunostimulant is used.
Participants/Inclusion and exclusion criteria
Perforated appendix during iatrogenic surgery. Having infectious peritonitis. Removing digestive fistulas. Removing mesh.
Intervention groups
The intervention group will receive an intravenous antibiotic prophylaxis with or without oral immunostimulants, orally, three times a day, one capsule, for 10 days. In the control group: After abdominal surgery, antibiotics will receive prophylaxis for 10 days.
Main outcome variables
Prevention of post-surgical infections of cannamis wounds

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20161017030336N6
Registration date: 2019-04-15, 1398/01/26
Registration timing: registered_while_recruiting

Last update: 2019-04-15, 1398/01/26
Update count: 0
Registration date
2019-04-15, 1398/01/26
Registrant information
Name
Ghasem Habibi
Name of organization / entity
Islamic azad university
Country
Iran (Islamic Republic of)
Phone
+98 86 3367 3208
Email address
dr.habibi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-25, 1397/12/06
Expected recruitment end date
2019-04-25, 1398/02/05
Actual recruitment start date
2019-02-25, 1397/12/06
Actual recruitment end date
2019-04-25, 1398/02/05
Trial completion date
2019-04-25, 1398/02/05
Scientific title
Comparison of prophylactic antibiotic and immunostimulant in preventing wound infection and abases after abdominal surgery.
Public title
Comparison of prophylactic antibiotic and immunostimulant in preventing wound infection and abases after abdominal surgery.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Perforated appendix during iatrogenic surgery. Having infectious peritonitis. Having digestive fistulas. Having a protruding mesh.
Exclusion criteria:
Use of drugs that suppress the patient's immune system, such as contortionists or toxicity drugs.
Age
From 14 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
Actual sample size reached: 60
Randomization (investigator's opinion)
Not 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
Ethics Committee of Arak University of Medical Sciences
Street address
Basidj Bridge, Sadasht.
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2019-02-24, 1397/12/05
Ethics committee reference number
IR.ARAKMU.REC.1397.344

Health conditions studied

1

Description of health condition studied
Acute appendicitis with generalized peritonitis
ICD-10 code
K35.2
ICD-10 code description
Acute appendicitis with generalized peritonitis

2

Description of health condition studied
Acute appendicitis with localized peritonitis
ICD-10 code
K35.3
ICD-10 code description
Acute appendicitis with localized peritonitis

3

Description of health condition studied
Acute appendicitis
ICD-10 code
K35.8
ICD-10 code description
Other and unspecified acute appendicitis

4

Description of health condition studied
Infectious peritonitis
ICD-10 code
A54.2
ICD-10 code description
Gonococcal pelviperitonitis and other gonococcal genitourinary infections

5

Description of health condition studied
Fistula of intestine
ICD-10 code
K63.2
ICD-10 code description
Fistula of intestine

6

Description of health condition studied
Complications of surgical wound
ICD-10 code
T81.4
ICD-10 code description
Infection following a procedure

Primary outcomes

1

Description
Prevention of post-surgical infections of cannamis wounds
Timepoint
24 hours after surgery for up to 10 days after surgery
Method of measurement
Performing microbial culture from the site of surgery

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 30 patients who underwent abdominal surgery in the ward of surgery at Vali Asr Hospital in Arak, after prophylaxis antibiotic surgery with orphan medicinal product Gol-Dara, orally, three times a day, one capsule, for a period of Will receive 10 days. All patients are examined for signs of infection, inflammation, hematoma, and ulcers and serum openings before being hospitalized.
Category
Treatment - Drugs

2

Description
Control group: Control group: 30 patients undergoing abdominal surgery in the ward of surgery at Vali-Asr Hospital in Arak, and will receive prophylaxis after antibiotic surgery. All patients are examined for signs of infection, inflammation, hematoma, and ulcers and serum openings before being hospitalized.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hospital of Vali Asr Arak
Full name of responsible person
Dr. Ali Davoodi
Street address
Pardis of Arak University of Medical Sciences, Sardasht, Basidj Bidge, Arak, IR. IRAN
City
ARAK
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
alidavoodi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Research Assistant of Arak University of Medical Sciences:Dr. Mohammad Arjomandzadegan
Street address
Pardis of Arak University of Medical Sciences, Sardasht, Basidj Bidge, Arak, IR. IRAN
City
arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
mmatinam81@yahoo.com
Grant name
Grant code / Reference number
1397.344
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr.Ali Davoodi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Pardis of Arak University of Medical Sciences, Sardasht, Basidj Bidge, Arak, IR. IRAN
City
arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
alidavoodi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Amir Reza Na'imi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Pardis of Arak University of Medical Sciences, Sardasht, Basidj Bidge, Arak, IR. IRAN
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
amirrezanaimi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ghasem Habibi
Position
Research Assistant
Latest degree
Bachelor
Other areas of specialty/work
Traditional Medicine
Street address
Pardis of Arak University of Medical Sciences, Sardasht, Basidj Bidge, Arak, IR. IRAN
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
ghasemhabibi.chem@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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