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Non-Powered Negative Pressure Wound Therapy vs Open Technique for Pilonidal Disease (NPWTvsOT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03483480
Recruitment Status : Recruiting
First Posted : March 30, 2018
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Yasir Bashir, The National Children's Hospital, Tallaght

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.

Condition or disease Intervention/treatment Phase
Pilonidal Disease Pilonidal Sinus Procedure: NPWT for Pilonidal Surgery Procedure: Excision of Pilonidal sinus with normal dressing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Non-Powered Negative Pressure Wound Therapy vs Open Technique for Pilonidal Disease
Actual Study Start Date : May 21, 2018
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Non powered-NPWT Procedure: NPWT for Pilonidal Surgery
After excision of pilonidal sinus Non powered-NPWT will be applied to the area

Active Comparator: Open Technique Procedure: Excision of Pilonidal sinus with normal dressing
After excision of pilonidal sinus normal dressing will be applied to the area of surgery




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. VAS score (Visual Analogue Scale) [ Time Frame: 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

  2. Wound size ratio [ Time Frame: Wound size ratio will be recorded at 1 week to 6 weeks at weekly intervals ]
    Healing as ratio of the initial wound

  3. Time to resume daily activities [ Time Frame: 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

  4. Recurrence [ Time Frame: Patient will be assessed at 6 months from surgery ]
    Recurrence of disease at 6 months from surgery

  5. Analgesia Requirement [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03483480


Locations
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Ireland
Tallaght Hospital Recruiting
Dublin, Ireland, D24 NR0A
Contact: Yasir Bashir, MBBS, MRCS    0035314142000 ext 2213    Yasir.Bashir@amnch.ie   
Contact: Emma Farrell    0035314142000 ext 2211    emma.farrell@amnch.ie   
Sponsors and Collaborators
The National Children's Hospital, Tallaght

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Responsible Party: Yasir Bashir, Assistant Professor of Surgery, The National Children's Hospital, Tallaght
ClinicalTrials.gov Identifier: NCT03483480    
Other Study ID Numbers: 2018-02
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pilonidal Sinus
Cysts
Neoplasms