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Minimally Invasive Treatment Methods for Pilonidal Disease

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ClinicalTrials.gov Identifier: NCT03070028
Recruitment Status : Not yet recruiting
First Posted : March 3, 2017
Last Update Posted : February 7, 2018
Sponsor:
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.

Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Phenol
U.S. FDA Resources

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.



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

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 ClinicalTrials.gov identifier (NCT number): NCT03070028


Contacts
Contact: Barış Sevinç, M.D. 5054880511 baris.sevinc@usak.edu.tr

Sponsors and Collaborators
Uşak University
Investigators
Principal Investigator: Barış Sevinç, M.D. Uşak University Medical School

Responsible Party: Barış Sevinç, assistant proffessor, Uşak University
ClinicalTrials.gov Identifier: NCT03070028     History of Changes
Other Study ID Numbers: PS001
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
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:
Pilonidal Sinus
Cysts
Neoplasms
Phenol
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Sclerosing Solutions
Pharmaceutical Solutions