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

NCT03483480 | Unknown

• 1 other identifier: 2018-02
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pilonidal Disease; Pilonidal Sinus

Outcome Measures

Primary Outcomes (1)

• Time to complete wound healing

  Time between Surgery and complete healing when there is no further requirement to apply dressing

  Wound will be assessed for healing at 1 week to 6 weeks

Secondary Outcomes (5)

• VAS score (Visual Analogue Scale)

  VAS for pain will be recorded at 1 week to 6 weeks at weekly intervals

• Wound size ratio

  Wound size ratio will be recorded at 1 week to 6 weeks at weekly intervals

• Time to resume daily activities

  Assessment will be done at 1 week to 6 weeks at weekly intervals

• Recurrence

  Patient will be assessed at 6 months from surgery

• Analgesia Requirement

  Recording will be done at 1 week to 6 weeks at weekly intervals

Study Arms (2)

Non powered-NPWT

EXPERIMENTAL

Procedure: NPWT for Pilonidal Surgery

Open Technique

ACTIVE COMPARATOR

Procedure: Excision of Pilonidal sinus with normal dressing

Interventions

NPWT for Pilonidal Surgery PROCEDURE

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

Non powered-NPWT

Excision of Pilonidal sinus with normal dressing PROCEDURE

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

Open Technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The National Children's Hospital, Tallaght: lead

Study Sites (1)

Tallaght Hospital

Dublin, D24 NR0A, Ireland

RECRUITING

MeSH Terms

Conditions

Pilonidal Sinus

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Cysts; Neoplasms

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

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 Professor of Surgery

Study Record Dates

• First Submitted: March 17, 2018
• First Posted: March 30, 2018
• Study Start: May 21, 2018
• Primary Completion: October 30, 2019
• Study Completion: November 30, 2019
• Last Updated: April 5, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
• Time Frame: data will be available on request for 3 months at publication of study
• Access Criteria: Send email to Principal Investigator with query and information needed. Principal Investigator will reply as soon as possible and provide the information requested.

Locations

IE (1)