Determining the effect of using silver nitrate and platelet fibrin glue in the treatment of anal fistulas
Design
A non-randomized, uncontrolled, single clinical trial will be conducted in phase 2 on 10 patients.
Settings and conduct
Imam Reza and Qaim Hospital
Participants/Inclusion and exclusion criteria
1. Patients who have a perianal fistula resistant to surgical treatment as diagnosed by a medical specialist;
2. Patients should be over 18 years old;
3. Obtain written consent
4. Patients who, in addition to anal fistula, have other urinary fistulas/active infection/carcinoma in situ/tumor will not be included in the study.
Intervention groups
The intervention group includes individuals with perianal fistula resistant to surgical treatment. In the operating room, 2 ml of 10% silver nitrate will first be injected into their perianal fistula channel. Then 5 ml of platelet-rich fibrin glue will also be injected into the fistula.
Main outcome variables
Reepithelialisation and fistula closure;
The disappearance of evidence of discharge and inflammation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191228045924N4
Registration date:2023-03-25, 1402/01/05
Registration timing:prospective
Last update:2023-03-25, 1402/01/05
Update count:0
Registration date
2023-03-25, 1402/01/05
Registrant information
Name
Daryoush Hamidi Alamdari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 8574
Email address
hamidiad@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2023-10-23, 1402/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The use of silver nitrate and platelet fibrin glue in the treatment of anal fistulas
Public title
Investigating the effect of using silver nitrate and platelet fibrin glue in the treatment of anal fistulas
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have a perianal fistula resistant to surgical treatment as diagnosed by a medical specialist
Patients should be over 18 years old
Obtain written consent
Exclusion criteria:
Patients who, in addition to anal fistula, have other urinary fistulas/active infection/carcinoma in situ/tumor.
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics committees of Mashhad University of Medical Sciences
Street address
Daneshgah street, the central organization of University, Quraishi construction
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2023-03-04, 1401/12/13
Ethics committee reference number
IR.MUMS.REC.1401.405
Health conditions studied
1
Description of health condition studied
Anal fistula
ICD-10 code
K60.3
ICD-10 code description
Anal fistula
Primary outcomes
1
Description
discharge amount
Timepoint
Before the intervention and after the intervention every 24 hours
Method of measurement
By visual observation of the dressing that is placed on the fistula site
2
Description
The duration of recovery, which is the number of days it takes for the discharge from the fistula to stop.
Timepoint
Every 24 hours (every day)
Method of measurement
By visual observation of the dressing that is placed on the fistula site
3
Description
Presence of inflammation and infection
Timepoint
Before the intervention and after the intervention every week for one month
Method of measurement
Clinical examination
Secondary outcomes
1
Description
Reepithelialisation and fistula closure
Timepoint
During the 6-month follow-up period of the patient
Method of measurement
clinical examination
Intervention groups
1
Description
The intervention group includes individuals with perianal fistula resistant to surgical treatment. In the operating room, 2 ml of 10% silver nitrate will first be injected into their perianal fistula channel. Then 5 ml of platelet-rich fibrin glue will also be injected into the fistula.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Amin Dalili
Street address
Iman Reza Hospital, Daneshgah Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
DaliliAM@mums.ac.ir
2
Recruitment center
Name of recruitment center
Qaim Hospital
Full name of responsible person
Zahra Gholami Moalem
Street address
Ghaem Hospital, Ahmadabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9187145785
Phone
+98 51 3840 0000
Email
gholamidr1@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour Mobarhan
Street address
Daneshgah Street, Central Organization of University, Qurashi Building
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
presidentoffice@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Daryoush Hamidi Alamdari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Iman Reza Hospital, Daneshgah Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
hamidiad@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Daryoush Hamidi Alamdari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Daneshgah Street, Surgical Oncology Research Center, Mashhad University of Medical Sciences, General Surgery Department, Building No. 2, Imam Reza hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9133913716
Phone
+98 51 3854 3031
Email
hamidiad@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Daryoush Hamidi Alamdari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Surgical Oncology Research Center, Mashhad University of Medical Sciences, General Surgery Department, Building No. 2, Imam Reza hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9133913716
Phone
+98 51 3854 3031
Email
hamidiad@mums.ac.ir
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
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
All data related to the project after the unidentifiable people will be shared.
When the data will become available and for how long
Access to data is allowed 6 months after the publication of results.
To whom data/document is available
Our data will be available for university staff and academic institutions
Under which criteria data/document could be used
According to the policies of the journal in which the article will be published, the data will be made available.
From where data/document is obtainable
The corresponding author of the article
What processes are involved for a request to access data/document
The request should be sent by email to the corresponding author and he will respond as soon as possible after reviewing the request.