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

Not Applicable

• Conditions: Pilonidal Disease; Pilonidal Sinus
• Interventions: Procedure: Excision of Pilonidal sinus with normal dressing; Procedure: NPWT for Pilonidal Surgery

• Registration Number: NCT03483480
• Lead Sponsor: The National Children's Hospital, Tallaght

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-17
• Study First Submitted QC: 2018-03-29
• Study First Posted: 2018-03-30
• Study Start: 2018-05-21
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-04
• Last Update Posted: 2019-04-05
• Primary Completion: 2019-10-30
• Study Completion: 2019-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open Technique	Excision of Pilonidal sinus with normal dressing	-
Non powered-NPWT	NPWT for Pilonidal Surgery	-

Primary Outcome Measures

Name	Time	Method
Time to complete wound healing	Wound will be assessed for healing at 1 week to 6 weeks	Time between Surgery and complete healing when there is no further requirement to apply dressing

Secondary Outcome Measures

Name	Time	Method
VAS score (Visual Analogue Scale)	VAS for pain will be recorded at 1 week to 6 weeks at weekly intervals	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
Analgesia Requirement	Recording will be done at 1 week to 6 weeks at weekly intervals	Requirement for analgesia will be recorded to make the pain analysis more robust
Wound size ratio	Wound size ratio will be recorded at 1 week to 6 weeks at weekly intervals	Healing as ratio of the initial wound
Time to resume daily activities	Assessment will be done at 1 week to 6 weeks at weekly intervals	Time at which patient is able to do his/her daily household works
Recurrence	Patient will be assessed at 6 months from surgery	Recurrence of disease at 6 months from surgery

Trial Locations

Locations (1)

Tallaght Hospital; 🇮🇪 Dublin, Ireland