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

Study Overview
=================
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.

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

Conditions
-----------------
Pilonidal Disease, Pilonidal Sinus

Intervention / Treatment
-----------------
* Procedure: NPWT for Pilonidal Surgery
* Procedure: Excision of Pilonidal sinus with normal dressing


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non powered-NPWT<br> | Procedure: NPWT for Pilonidal Surgery<br>* After excision of pilonidal sinus Non powered-NPWT will be applied to the area<br>|
| Active Comparator: Open Technique<br> | Procedure: Excision of Pilonidal sinus with normal dressing<br>* After excision of pilonidal sinus normal dressing will be applied to the area of surgery<br>|

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 |