Back to resultsNon-Powered Negative Pressure Wound Therapy vs Open Technique for Pilonidal Disease (NPWTvsOT)
Primary Purpose
Pilonidal Disease, Pilonidal Sinus
Status
Unknown status
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
NPWT for Pilonidal Surgery
Excision of Pilonidal sinus with normal dressing
Sponsored by
About this trial
This is an interventional treatment trial for Pilonidal Disease
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.
Sites / Locations
- Tallaght HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Non powered-NPWT
Open Technique
Arm Description
Outcomes
Primary Outcome Measures
Time to complete wound healing
Time between Surgery and complete healing when there is no further requirement to apply dressing
Secondary Outcome Measures
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
Wound size ratio
Healing as ratio of the initial wound
Time to resume daily activities
Time at which patient is able to do his/her daily household works
Recurrence
Recurrence of disease at 6 months from surgery
Analgesia Requirement
Requirement for analgesia will be recorded to make the pain analysis more robust
Full Information
NCT ID
NCT03483480
First Posted
March 17, 2018
Last Updated
April 4, 2019
Sponsor
The National Children's Hospital, Tallaght
1. Study Identification
Unique Protocol Identification Number
NCT03483480
Brief Title
Non-Powered Negative Pressure Wound Therapy vs Open Technique for Pilonidal Disease
Acronym
NPWTvsOT
Official Title
Randomized Controlled Trial of Non-Powered Negative Pressure Wound Therapy vs Open Technique for Pilonidal Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 21, 2018 (Actual)
Primary Completion Date
October 30, 2019 (Anticipated)
Study Completion Date
November 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The National Children's Hospital, Tallaght
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pilonidal Disease, Pilonidal Sinus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Non powered-NPWT
Arm Type
Experimental
Arm Title
Open Technique
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
NPWT for Pilonidal Surgery
Intervention Description
After excision of pilonidal sinus Non powered-NPWT will be applied to the area
Intervention Type
Procedure
Intervention Name(s)
Excision of Pilonidal sinus with normal dressing
Intervention Description
After excision of pilonidal sinus normal dressing will be applied to the area of surgery
Primary Outcome Measure Information:
Title
Time to complete wound healing
Description
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
Secondary Outcome Measure Information:
Title
VAS score (Visual Analogue Scale)
Description
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
Title
Wound size ratio
Description
Healing as ratio of the initial wound
Time Frame
Wound size ratio will be recorded at 1 week to 6 weeks at weekly intervals
Title
Time to resume daily activities
Description
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
Title
Recurrence
Description
Recurrence of disease at 6 months from surgery
Time Frame
Patient will be assessed at 6 months from surgery
Title
Analgesia Requirement
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Tallaght Hospital
City
Dublin
ZIP/Postal Code
D24 NR0A
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasir Bashir, MBBS, MRCS
Phone
0035314142000
Ext
2213
Email
Yasir.Bashir@amnch.ie
First Name & Middle Initial & Last Name & Degree
Emma Farrell
Phone
0035314142000
Ext
2211
Email
emma.farrell@amnch.ie
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
data will be available on request for 3 months at publication of study
IPD Sharing 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.
Learn more about this trial
Non-Powered Negative Pressure Wound Therapy vs Open Technique for Pilonidal Disease
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