PRP Use in Treatment of Fistula Ano
Primary Purpose
Fistula in Ano
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
platelet rich plasma
Sponsored by
About this trial
This is an interventional treatment trial for Fistula in Ano
Eligibility Criteria
Inclusion Criteria:
- patients with perianal fistula
- signing the informed consent form
- above the age of 18
Exclusion Criteria:
- inflammatory bowel disease
- previous radiation therapy
- having connective tissue disorders
Sites / Locations
- Uşak UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PRP gel application
Arm Description
PRP application for perianal fistula
Outcomes
Primary Outcome Measures
percentage of the cure rate
closure of the fistula tract will be evaluated by physical examination and magnetic resonance imaging
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04187651
Brief Title
PRP Use in Treatment of Fistula Ano
Official Title
Use of Platelet Rich Plasma in Treatment of Perianal Fistula
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 20, 2019 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uşak University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In treatment of perianal fistula several methods are described. However, since the Hippocrates basics of surgical treatment has not changed very much. the aim of this study is to evaluate the effectiveness of PRP gel in treatment of perianal fistula.
Detailed Description
Perianal fistula is a chronic condition that seriously affects the patients' quality of life. There are different treatment modalities used in treatment. Recently sphincter preserving methods are becoming more popular with low complication rates. Most of this methods aiming the closure of fistula tract by different pathways.
Platelet rich plasma (PRP) is used in a wide range of conditions in medicine. The investigator's team showed the effective treatment of pilonidal disease by use of PRP gel. In the recent study, aim to evaluate the effectiveness of PRP gel in treatment of perianal fistula.
Patients with perianal fistula will be evaluated for the study. After taking permission with informed consent; cases will be included in the study. Cases with inflammatory bowel disease, platelet function disorders or connective tissue disorders that may alter wound healing will be excluded from the study.
After, PRP application to the fistula tract patients will be taken to follow up. Perianal fistulas will be followed by magnetic resonance imaging 1 month after the application. Pre-application and post-application scans will be used for the evaluation of the treatment success.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fistula in Ano
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
PRP gel will be applicated to all cases
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PRP gel application
Arm Type
Experimental
Arm Description
PRP application for perianal fistula
Intervention Type
Other
Intervention Name(s)
platelet rich plasma
Intervention Description
platelet rich plasma prepared from the patients' own blood will be applied to the fistula tract
Primary Outcome Measure Information:
Title
percentage of the cure rate
Description
closure of the fistula tract will be evaluated by physical examination and magnetic resonance imaging
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with perianal fistula
signing the informed consent form
above the age of 18
Exclusion Criteria:
inflammatory bowel disease
previous radiation therapy
having connective tissue disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barış Sevinç, M.D.
Phone
+905054880511
Email
drbarissevinc@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nurullah Damburacı, M.D.
Phone
905058726249
Email
nurullahdamburaci@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barış Sevinç, M.D.
Organizational Affiliation
Uşak University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uşak University
City
Uşak
ZIP/Postal Code
64100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barış Sevinç
Phone
5054880511
Email
drbarissevinc@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
PRP Use in Treatment of Fistula Ano
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