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Metronidazole Ointment in Non-healing Pilonidal Sinus Wounds

NCT04273997 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-09-22

No results posted yet for this study

Summary

Title of Study:

Randomised, double-blind, placebo-controlled trial evaluating the effects of metronidazole ointment in facilitating resolution on non-healing pilonidal sinus wounds Medical Condition Under Investigation Non-healing pilonidal sinus wounds

Study centres: 2 Centres in Turkey

Clinical Phase: Phase 2

Protocol Number: MET-PS-02

Study Design: Randomised, double-blind, placebo-controlled, parallel group study to determine the safety and efficacy of metronidazole ointment applied to the wound, following debridement in non-healing pilonidal sinus wounds.

Planned Sample Size: 80 subjects

Conditions

  • Pilonidal Sinus

Interventions

DRUG

Metronidazole 10% ointment

Metronidazole 10% ointment

DRUG

Placebo ointment

Placebo ointment

Sponsors & Collaborators

  • S.L.A. Pharma AG

    lead INDUSTRY

Principal Investigators

  • Arda Isik · Study Principal Investigator

  • Ozan Kucuk · Study Principal Investigator

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2022-02-01
Completion
2022-05-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04273997 on ClinicalTrials.gov