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Clinical Trials/NCT01963273
NCT01963273UnknownNot Applicable

Video Assisted Ablation of Pilonidal Sinus. Evaluation of Safety and Efficacy of a New Minimally Invasive Technique

Federico II University2 sites in 1 country200 target enrollmentStarted: September 1, 2013Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
200
Locations
2
Primary Endpoint
Infection
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The investigators supposed that the complete video assisted ablation of pilonidal sinus (VAAPS) could be an effective minimally invasive treatment of pilonidal sinus. This new minimally invasive treatment allows the identification of the sinus cavity with its lateral tracks, the destruction and the removal of all infected tissue and the removing of any hair.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
15 Years to 90 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Diagnosis of chronic pilonidal sinus

Exclusion Criteria

  • •Inability to consent to the study Recurrent pilonidal sinus after an outmidline technique

Outcomes

Primary Outcomes

Infection

Time Frame: 1 month

Wound infection was defined as redness and/or oedema of the skin and/or discharge

Secondary Outcomes

  • Recurrence(1 year)

Investigators

Sponsor
Federico II University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Francesco Milone

Professor

Federico II University

Study Sites (2)

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