Pilonidal DiseaseNPWTvsOTNCT03483480
Non-Powered Negative Pressure Wound Therapy vs Open Technique for Pilonidal Disease
A study testing NPWT for Pilonidal Surgery and Excision of Pilonidal sinus with normal dressing in people with Pilonidal Disease and Pilonidal Sinus, run by The National Children's Hospital, Tallaght at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pilonidal Disease, Pilonidal Sinus
- What is being tested?
- NPWT for Pilonidal Surgery and Excision of Pilonidal sinus with normal dressing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteIreland
- Study dates
- 21 May 2018to 30 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient suffering from Pilonidal Disease willing to participate in study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
Tallaght Hospital
Dublin, D24 NR0A
Yasir Bashir, MBBS, MRCS, 0035314142000 ext. 2213, Yasir.Bashir@amnch.ie
Emma Farrell, 0035314142000 ext. 2211, emma.farrell@amnch.ie
About this study
Official title: Randomized Controlled Trial of Non-Powered Negative Pressure Wound Therapy vs Open Technique for Pilonidal Disease
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.
- Conditions
- Pilonidal Disease, Pilonidal Sinus
- Being tested
- NPWT for Pilonidal Surgery, Excision of Pilonidal sinus with normal dressing
- Medical subject headings
- Pilonidal Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPWT for Pilonidal SurgeryProcedure or surgery
After excision of pilonidal sinus Non powered-NPWT will be applied to the area
Excision of Pilonidal sinus with normal dressingProcedure or surgery
After excision of pilonidal sinus normal dressing will be applied to the area of surgery
| Study group | Role | What they receive |
|---|---|---|
| Non powered-NPWT | Experimental | Not described Receives: Procedure: NPWT for Pilonidal Surgery |
| Open Technique | Active comparator | Not described Receives: Procedure: Excision of Pilonidal sinus with normal dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to complete wound healing
Time between Surgery and complete healing when there is no further requirement to apply dressing
Measured: Wound will be assessed for healing at 1 week to 6 weeks
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: Assessment will be done at 1 week to 6 weeks at weekly intervals
Recurrence
Recurrence of disease at 6 months from surgery
Measured: Patient will be assessed at 6 months from surgery
Analgesia Requirement
Requirement for analgesia will be recorded to make the pain analysis more robust
Measured: Recording will be done at 1 week to 6 weeks at weekly intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start21 May 2018
- Primary completion30 Oct 2019 (estimated)
- Study completion30 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pilonidal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The National Children's Hospital, Tallaght
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasir Bashir, The National Children's Hospital, Tallaght
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03483480
- Sponsor's protocol ID
- 2018-02
- Acronym
- NPWTvsOT
- Status last verified
- Apr 2019
- First submitted
- 17 Mar 2018
- Last updated
- 5 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Non-Powered Negative Pressure Wound Therapy vs Open Technique for Pilonidal Disease
- ClinicalTrials.gov ID
- NCT03483480
- Acronym / sponsor ID
- NPWTvsOT / 2018-02
- Conditions
- Pilonidal Disease, Pilonidal Sinus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- The National Children's Hospital, TallaghtUniversity, hospital or other
- Study start
- 21 May 2018 (actual)
- Primary completion
- 30 Oct 2019 (estimated)
- Study completion
- 30 Nov 2019 (estimated)
- First posted
- 30 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non powered-NPWT | Experimental | Procedure: NPWT for Pilonidal Surgery |
| Open Technique | Active comparator | Procedure: Excision of Pilonidal sinus with normal dressing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patient suffering from Pilonidal Disease willing to participate in study.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NPWT for Pilonidal SurgeryAfter excision of pilonidal sinus Non powered-NPWT will be applied to the area | Procedure or surgery | Non powered-NPWT |
| Excision of Pilonidal sinus with normal dressingAfter excision of pilonidal sinus normal dressing will be applied to the area of surgery | Procedure or surgery | Open Technique |
Primary outcome
Time to complete wound healing
Time frame: 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
5 secondary outcomes
VAS score (Visual Analogue Scale)
Time frame: VAS for pain will be recorded at 1 week to 6 weeks at weekly intervals
Wound size ratio
Time frame: Wound size ratio will be recorded at 1 week to 6 weeks at weekly intervals
Time to resume daily activities
Time frame: Assessment will be done at 1 week to 6 weeks at weekly intervals
Recurrence
Time frame: Patient will be assessed at 6 months from surgery
Analgesia Requirement
Time frame: Recording will be done at 1 week to 6 weeks at weekly intervals
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NPWT for Pilonidal Surgery and Excision of Pilonidal sinus with normal dressing in people with Pilonidal Disease and Pilonidal Sinus, run by The National Children's Hospital, Tallaght at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to complete wound healing (time frame: Wound will be assessed for healing at 1 week to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2019.