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PRP Use in Treatment of Fistula Ano

Sponsor
Uşak University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04187651
Collaborator
(none)
100
Enrollment
1
Location
1
Arm
48.4
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: platelet rich plasma
 N/A

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

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
PRP gel will be applicated to all casesPRP gel will be applicated to all cases
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Use of Platelet Rich Plasma in Treatment of Perianal Fistula
Actual Study Start Date :
Nov 20, 2019
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: PRP gel application

PRP application for perianal fistula

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

Outcome Measures

Primary Outcome Measures

  1. percentage of the cure rate [1 month]

    closure of the fistula tract will be evaluated by physical examination and magnetic resonance imaging

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Uşak University Uşak Turkey 64100

Sponsors and Collaborators

  • Uşak University

Investigators

  • Principal Investigator: Barış Sevinç, M.D., Uşak University Medical School

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Barış Sevinç, Assoc. Prof., Uşak University
ClinicalTrials.gov Identifier:
NCT04187651
Other Study ID Numbers:
  • PRPF
First Posted:
Dec 5, 2019
Last Update Posted:
May 4, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Fistula

Study Results

No Results Posted as of May 4, 2021