Pilonidal Disease, Pilonidal Sinus
Conditions
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.
Interventions
PROCEDURENPWT for Pilonidal Surgery
After excision of pilonidal sinus Non powered-NPWT will be applied to the area
PROCEDUREExcision of Pilonidal sinus with normal dressing
After excision of pilonidal sinus normal dressing will be applied to the area of surgery
Sponsors
The National Children's Hospital, Tallaght
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
Countries
Ireland
Outcome results
None listed