Non-Powered Negative Pressure Wound Therapy vs Open Technique for Pilonidal Disease

NCT ID: NCT03483480

Last Updated: 2019-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-21

Study Completion Date

2019-11-30

Brief Summary

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Pilonidal Disease is disease of young patients with significant morbidity and is difficult to treat. Currently multiple methods are practiced for the treatment of the disease, two of them are preferred over others and practice extensively. First one involves excision of pilonidal sinus and dressings while the second one is excision of the pilonidal sinus with application of negative pressure wound therapy. None of these approaches is considered superior to the other, as not enough comparison studies of the two procedures have been done. In order to clarify this and find the best option for our patients, investigators are taking opportunity to compare these two modalities. If participants choose to participate in this study they will be randomly selected to one of these groups and the progress of wound healing will be monitored after surgery with the measurement of wound weekly and photographs. Investigators are hoping to find out which procedure is superior. This will allow investigators to provide the best treatment option for their patients in future.

Detailed Description

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Conditions

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Pilonidal Disease Pilonidal Sinus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Non powered-NPWT

Group Type EXPERIMENTAL

NPWT for Pilonidal Surgery

Intervention Type PROCEDURE

After excision of pilonidal sinus Non powered-NPWT will be applied to the area

Open Technique

Group Type ACTIVE_COMPARATOR

Excision of Pilonidal sinus with normal dressing

Intervention Type PROCEDURE

After excision of pilonidal sinus normal dressing will be applied to the area of surgery

Interventions

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NPWT for Pilonidal Surgery

After excision of pilonidal sinus Non powered-NPWT will be applied to the area

Intervention Type PROCEDURE

Excision of Pilonidal sinus with normal dressing

After excision of pilonidal sinus normal dressing will be applied to the area of surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Adult patient suffering from Pilonidal Disease willing to participate in study.

Exclusion Criteria

* Patients below the age of 16 years (not able to consent).
* Not consenting to participate in study.
* Patient with less than 3 cm between inferior opening of sinus and anus.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The National Children's Hospital, Tallaght

OTHER

Sponsor Role lead

Responsible Party

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Yasir Bashir

Assistant Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tallaght Hospital

Dublin, , Ireland

Site Status RECRUITING

Countries

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Ireland

Facility Contacts

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Yasir Bashir, MBBS, MRCS

Role: primary

0035314142000 ext. 2213

Emma Farrell

Role: backup

0035314142000 ext. 2211

Other Identifiers

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2018-02

Identifier Type: -

Identifier Source: org_study_id

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