NCT03070028

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 3, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

May 13, 2020

Status Verified

May 1, 2020

Enrollment Period

2.9 years

First QC Date

February 28, 2017

Last Update Submit

May 11, 2020

Conditions

Pilonidal Sinus

Outcome Measures

Primary Outcomes (1)

  • healing time

    Time to complete closure of the sinus cavity.

    first 1 year of the study

Study Arms (2)

Phenol

EXPERIMENTAL

crystallised phenol application

Procedure: crystallised phenol

platelet rich plasma

EXPERIMENTAL

PRP application

Procedure: Platelet rich plasma

Interventions

crystallised phenolPROCEDURE

crystallised phenol will be applied to sinus cavity

Phenol
Platelet rich plasmaPROCEDURE

platelet rich plasma will be applied to sinus cavity

platelet rich plasma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uşak University

Uşak, 64100, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 34629430DERIVED

MeSH Terms

Conditions

Pilonidal Sinus

Condition Hierarchy (Ancestors)

CystsNeoplasms

Study Officials

  • Barış Sevinç, M.D.

    Uşak University Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant proffessor

Study Record Dates

First Submitted

February 28, 2017

First Posted

March 3, 2017

Study Start

January 1, 2017

Primary Completion

December 1, 2019

Study Completion

May 1, 2020

Last Updated

May 13, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)