PRP Use in Treatment of Fistula Ano

Fistula in Ano Clinical Trial

Official title:

Use of Platelet Rich Plasma in Treatment of Perianal Fistula

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04187651
• Other study ID #: PRPF
• Status: Recruiting
• Phase: N/A
• Start date: November 20, 2019
• Est. completion date: December 1, 2025

Study information

• Verified date: May 2023
• Source: Usak University
• Contact: Baris Sevinç, M.D.
• Phone: +905054880511
• Email: drbarissevinc[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fistula
• Fistula in Ano

Intervention

Other:
• platelet rich plasma
platelet rich plasma prepared from the patients' own blood will be applied to the fistula tract

Locations

Country	Name	City	State
Turkey	Usak University	Usak

Sponsors (1)

Lead Sponsor	Collaborator
Usak University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of the cure rate	closure of the fistula tract will be evaluated by physical examination and magnetic resonance imaging	1 month