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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non powered-NPWT | Experimental |
| |
| Open Technique | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NPWT for Pilonidal Surgery | Procedure | After excision of pilonidal sinus Non powered-NPWT will be applied to the area |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tallaght Hospital | Recruiting | Dublin | D24 NR0A | Ireland |
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data will be available on request for 3 months at publication of study
Send email to Principal Investigator with query and information needed. Principal Investigator will reply as soon as possible and provide the information requested.
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| ID | Term |
|---|---|
| D010864 | Pilonidal Sinus |
| ID | Term |
|---|---|
| D003560 | Cysts |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D054843 | Negative-Pressure Wound Therapy |
| ID | Term |
|---|---|
| D004322 | Drainage |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D058106 | Wound Closure Techniques |
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| Excision of Pilonidal sinus with normal dressing | Procedure | After excision of pilonidal sinus normal dressing will be applied to the area of surgery |
|
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 |