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

Randomized Controlled Trial of Non-Powered Negative Pressure Wound Therapy vs Open Technique for Pilonidal Disease

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.

Study Overview

• Status: Unknown
• Conditions: Pilonidal Sinus; Pilonidal Disease
• Intervention / Treatment: Procedure: NPWT for Pilonidal Surgery; Procedure: Excision of Pilonidal sinus with normal dressing

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland, D24 NR0A
    • Recruiting
    • Tallaght Hospital
    • Contact: Yasir Bashir, MBBS, MRCS; Phone Number: 2213 0035314142000; Email: Yasir.Bashir@amnch.ie
    • Contact: Emma Farrell; Phone Number: 2211 0035314142000; Email: emma.farrell@amnch.ie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Non powered-NPWT	Procedure: NPWT for Pilonidal Surgery; After excision of pilonidal sinus Non powered-NPWT will be applied to the area
ACTIVE_COMPARATOR: Open Technique	Procedure: Excision of Pilonidal sinus with normal dressing; After excision of pilonidal sinus normal dressing will be applied to the area of surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS score (Visual Analogue Scale)	Pain score as scored by patients, VAS is an analogue scale is from 1 to 10, 1 being minimal discomfort to 10 being the worst pain in the life	VAS for pain will be recorded at 1 week to 6 weeks at weekly intervals
Wound size ratio	Healing as ratio of the initial wound	Wound size ratio will be recorded at 1 week to 6 weeks at weekly intervals
Time to resume daily activities	Time at which patient is able to do his/her daily household works	Assessment will be done at 1 week to 6 weeks at weekly intervals
Recurrence	Recurrence of disease at 6 months from surgery	Patient will be assessed at 6 months from surgery
Analgesia Requirement	Requirement for analgesia will be recorded to make the pain analysis more robust	Recording will be done at 1 week to 6 weeks at weekly intervals

Collaborators and Investigators

• Sponsor: The National Children's Hospital, Tallaght

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 21, 2018
• Primary Completion (ANTICIPATED): October 30, 2019
• Study Completion (ANTICIPATED): November 30, 2019

Study Registration Dates

• First Submitted: March 17, 2018
• First Submitted That Met QC Criteria: March 29, 2018
• First Posted (ACTUAL): March 30, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 5, 2019
• Last Update Submitted That Met QC Criteria: April 4, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Cysts; Pilonidal Sinus
• Other Study ID Numbers: 2018-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: data will be available on request for 3 months at publication of study
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No