Minimally Invasive Treatment Methods for Pilonidal Disease

May 11, 2020 updated by: Barış Sevinç, Uşak University

Randomized Prospective Comparison of Crystallized Phenol and Platelet Rich Plasma Applications in Treatment of Pilonidal Sinus Disease

Patients with pilonidal sinus disease will be randomised to two groups (crystallised phenol and platelet rich plasma). Sinus healing time, patient satisfaction, complications and recurrence rates will be compared.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with pilonidal sinus disease will be treated by either crystallised phenol or platelet rich plasma application. Treatment results, healing time, postprocedural complications, patient satisfaction and recurrences will be compared.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Uşak, Turkey, 64100
        • Uşak University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Having pilonidal sinus disease
  • accepting to be involved in the study

Exclusion Criteria:

  • below the age of 18
  • having connective tissue disorders
  • diabetes mellitus
  • severe anemia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Phenol
crystallised phenol application
Procedure: crystallised phenol
crystallised phenol will be applied to sinus cavity
EXPERIMENTAL: platelet rich plasma
PRP application
Procedure: Platelet rich plasma
platelet rich plasma will be applied to sinus cavity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
healing time
Time Frame: first 1 year of the study
Time to complete closure of the sinus cavity.
first 1 year of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uşak University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2017

Primary Completion (ACTUAL)

December 1, 2019

Study Completion (ACTUAL)

May 1, 2020

Study Registration Dates

First Submitted

February 28, 2017

First Submitted That Met QC Criteria

February 28, 2017

First Posted (ACTUAL)

March 3, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 13, 2020

Last Update Submitted That Met QC Criteria

May 11, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PS001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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