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Minimally Invasive Treatment Methods for Pilonidal Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03070028
Recruitment Status : Completed
First Posted : March 3, 2017
Last Update Posted : May 13, 2020
Information provided by (Responsible Party):
Barış Sevinç, Uşak University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pilonidal Sinus Procedure: crystallised phenol Procedure: Platelet rich plasma Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Prospective Comparison of Crystallized Phenol and Platelet Rich Plasma Applications in Treatment of Pilonidal Sinus Disease
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : December 1, 2019
Actual Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Phenol

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

Primary Outcome Measures :
  1. healing time [ Time Frame: first 1 year of the study ]
    Time to complete closure of the sinus cavity.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03070028

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Uşak University
Uşak, Turkey, 64100
Sponsors and Collaborators
Uşak University
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Principal Investigator: Barış Sevinç, M.D. Uşak University Medical School
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Responsible Party: Barış Sevinç, assistant proffessor, Uşak University Identifier: NCT03070028    
Other Study ID Numbers: PS001
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pilonidal Sinus
Anti-Infective Agents, Local
Anti-Infective Agents
Sclerosing Solutions
Pharmaceutical Solutions