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De-roofing and Curettage vs WLE for Pilonidal Abscess

NCT03415347 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2018-04-19

No results posted yet for this study

Summary

Pilonidal disease refers to a common disease affecting mostly young males. It may present as asymptomatic pits, acute and painful abscess formation, or chronic discharging sinuses. There are many treatment options for the latter two manifestations but broadly speaking the surgical treatment of acute pilonidal abscess can fall into three categories: (1) incision and drainage, (2) de-roofing and curettage and (3) wide local excision.

The evidence available for the surgical management of acute pilonidal abscess is limited. Previous studies have consistently demonstrated that incision and drainage results in high recurrence rates and should not be considered as the first-line treatment option for the management of acute pilonidal abscess. However, it is not clear whether abscess de-roofing with curettage or wide local excision should be considered as the surgical procedure of choice in acute pilonidal abscess. There has not been a prospective randomised study comparing abscess de-roofing with curettage and wide local excision for acute pilonidal abscess. The ideal surgical procedure would be one that results in the lowest rate of abscess recurrence, treats the underlying pilonidal sinus thereby reducing the need for re-operation but has acceptable post-operative pain, complications and time to complete wound healing.

Conditions

  • Pilonidal Abscess
  • Pilonidal Sinus With Abscess
  • Pilonidal Sinus Infected
  • Pilonidal Disease

Interventions

PROCEDURE

Abscess de-roofing and curettage

Abscess de-roofing and curettage

PROCEDURE

Abscess wide local excision

Abscess wide local excision

Sponsors & Collaborators

  • London North West Healthcare NHS Trust

    lead OTHER

Principal Investigators

  • Lalin Navaratne, MBBS MRCS · LONDON NORTH WEST UNIVERSITY HEALTHCARE NHS TRUST

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2019-11-30
Completion
2019-11-30

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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 NCT03415347 on ClinicalTrials.gov