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Minimally Invasive Treatment Methods for Pilonidal Disease

Primary Purpose

Pilonidal Sinus

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

crystallised phenol

Platelet rich plasma

About this trial

This is an interventional treatment trial for Pilonidal Sinus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Uşak University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Phenol

platelet rich plasma

Arm Description

crystallised phenol application

PRP application

Outcomes

Primary Outcome Measures

healing time

Time to complete closure of the sinus cavity.

Secondary Outcome Measures

Full Information

NCT ID

NCT03070028

First Posted

February 28, 2017

Last Updated

May 11, 2020

Sponsor

Uşak University

1. Study Identification

Unique Protocol Identification Number

NCT03070028

Brief Title

Minimally Invasive Treatment Methods for Pilonidal Disease

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

January 1, 2017 (Actual)

Primary Completion Date

December 1, 2019 (Actual)

Study Completion Date

May 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Uşak University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pilonidal Sinus

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Phenol

Arm Type

Experimental

Arm Description

crystallised phenol application

Arm Title

platelet rich plasma

Arm Type

Experimental

Arm Description

PRP application

Intervention Type

Procedure

Intervention Name(s)

crystallised phenol

Intervention Description

crystallised phenol will be applied to sinus cavity

Intervention Type

Procedure

Intervention Name(s)

Platelet rich plasma

Intervention Description

platelet rich plasma will be applied to sinus cavity

Primary Outcome Measure Information:

Title

healing time

Description

Time to complete closure of the sinus cavity.

Time Frame

first 1 year of the study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Barış Sevinç, M.D.

Organizational Affiliation

Uşak University Medical School

Official's Role

Principal Investigator

Facility Information:

Facility Name

Uşak University

City

Uşak

ZIP/Postal Code

64100

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34629430

Citation

Sevinc B, Damburaci N, Karahan O. Comparison of Curettage Plus Platelet-Rich Plasma Gel and Curettage Plus Phenol Application in Treatment of Pilonidal Sinus Disease: A Randomized Trial. Dis Colon Rectum. 2022 May 1;65(5):735-741. doi: 10.1097/DCR.0000000000002082.

Results Reference

derived

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Minimally Invasive Treatment Methods for Pilonidal Disease

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