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NCT03070028 Clinical Trial

Minimally Invasive Treatment Methods for Pilonidal Disease

Pilonidal Sinus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03070028
Other study ID # PS001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2017
Est. completion date May 1, 2020

Study information
Verified date May 2020
Source Usak University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date May 1, 2020
Est. primary completion date December 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• crystallised phenol
crystallised phenol will be applied to sinus cavity
• Platelet rich plasma
platelet rich plasma will be applied to sinus cavity

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 healing time Time to complete closure of the sinus cavity. first 1 year of the study
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