- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04187651
PRP Use in Treatment of Fistula Ano
Use of Platelet Rich Plasma in Treatment of Perianal Fistula
Study Overview
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Barış Sevinç, M.D.
- Phone Number: +905054880511
- Email: drbarissevinc@gmail.com
Study Contact Backup
- Name: Nurullah Damburacı, M.D.
- Phone Number: 905058726249
- Email: nurullahdamburaci@gmail.com
Study Locations
-
-
-
Uşak, Turkey, 64100
- Recruiting
- Uşak University
-
Contact:
- Barış Sevinç
- Phone Number: 5054880511
- Email: drbarissevinc@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PRP gel application
PRP application for perianal fistula
|
platelet rich plasma prepared from the patients' own blood will be applied to the fistula tract
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
percentage of the cure rate
Time Frame: 1 month
|
closure of the fistula tract will be evaluated by physical examination and magnetic resonance imaging
|
1 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Barış Sevinç, M.D., Uşak University Medical School
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRPF
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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