Fistula in AnoNCT04187651
PRP Use in Treatment of Fistula Ano
A study testing platelet rich plasma in people with Fistula in Ano, run by Uşak University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fistula in Ano
- What is being tested?
- platelet rich plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2019to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with perianal fistula
- signing the informed consent form
- above the age of 18
Who cannot join
- inflammatory bowel disease
- previous radiation therapy
- having connective tissue disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Platelet Rich Plasma in Treatment of Perianal Fistula
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.
Read the 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.
- Conditions
- Fistula in Ano
- Being tested
- platelet rich plasma
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platelet rich plasmaOther
platelet rich plasma prepared from the patients' own blood will be applied to the fistula tract
| Study group | Role | What they receive |
|---|---|---|
| PRP gel application | Experimental | PRP application for perianal fistula Receives: Other: platelet rich plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of the cure rate
closure of the fistula tract will be evaluated by physical examination and magnetic resonance imaging
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start20 Nov 2019
- Primary completion1 Jan 2025
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fistula in AnoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- PRP gel will be applicated to all cases
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uşak University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barış Sevinç, Uşak University
- Investigators
- Barış Sevinç, M.D., Principal investigator, Uşak University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04187651
- Sponsor's protocol ID
- PRPF
- Status last verified
- Apr 2026
- First submitted
- 2 Dec 2019
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Platelet Rich Plasma in Treatment of Perianal Fistula
- ClinicalTrials.gov ID
- NCT04187651
- Acronym / sponsor ID
- PRPF
- Conditions
- Fistula in Ano
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Uşak UniversityUniversity, hospital or other
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 5 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- PRP gel will be applicated to all cases
| Arm | Type | Receives |
|---|---|---|
| PRP gel application | Experimental | Other: platelet rich plasmaPRP application for perianal fistula |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with perianal fistula
- signing the informed consent form
- above the age of 18
Key exclusion criteria (3 listed)
- inflammatory bowel disease
- previous radiation therapy
- having connective tissue disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| platelet rich plasmaplatelet rich plasma prepared from the patients' own blood will be applied to the fistula tract | Other | PRP gel application |
Primary outcome
percentage of the cure rate
Time frame: 1 month
closure of the fistula tract will be evaluated by physical examination and magnetic resonance imaging
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barış Sevinç, M.D. principal investigator
Uşak University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing platelet rich plasma in people with Fistula in Ano, run by Uşak University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of the cure rate (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.