An interventional study of NPWT for Pilonidal Surgery and Excision of Pilonidal sinus with normal dressing in Pilonidal Disease and Pilonidal Sinus, sponsored by The National Children's Hospital, Tallaght. Status unknown at 1 site in Ireland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-05.
Sponsored by The National Children's Hospital, Tallaght · Not applicable, Interventional, and Treatment
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.
109 studies on the registry are indexed under Pilonidal Sinus; 32 are open to participants now.
This study's planned enrollment of 32 is below the median of 80 across 72 interventional studies indexed under Pilonidal Sinus.
Browse Pilonidal Sinus studies →The National Children's Hospital, Tallaght is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Procedure: NPWT for Pilonidal Surgery
Procedure: Excision of Pilonidal sinus with normal dressing
After excision of pilonidal sinus Non powered-NPWT will be applied to the area
After excision of pilonidal sinus normal dressing will be applied to the area of surgery
Time to complete wound healing
Time between Surgery and complete healing when there is no further requirement to apply dressing
Time frame: Wound will be assessed for healing at 1 week to 6 weeks
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
Time frame: 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
Time frame: 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
Time frame: Assessment will be done at 1 week to 6 weeks at weekly intervals
Recurrence
Recurrence of disease at 6 months from surgery
Time frame: Patient will be assessed at 6 months from surgery
Analgesia Requirement
Requirement for analgesia will be recorded to make the pain analysis more robust
Time frame: Recording will be done at 1 week to 6 weeks at weekly intervals
Plan to share: Yes
Supporting information: Study protocol, Informed consent form, Clinical study report, Analytic code
Time frame: data will be available on request for 3 months at publication of study
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.
No publications or documents are linked to this record.
Started May 2018 (actual). Primary completion is estimated for Oct 2019, 17 months after the start.
Of 35 interventional studies with no phase under Pilonidal Sinus, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 35. This study's planned 17 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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The National Children's Hospital, Tallaght