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

Pilonidal Sinus Clinical Trial

— NPWTvsOT  

Official title:

Randomized Controlled Trial of Non-Powered Negative Pressure Wound Therapy vs Open Technique for Pilonidal Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03483480
• Other study ID #: 2018-02
• Status: Recruiting
• Phase: N/A
• Start date: May 21, 2018
• Est. completion date: November 30, 2019

Study information

• Verified date: April 2019
• Source: The National Children's Hospital, Tallaght
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: November 30, 2019
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pilonidal Disease
• Pilonidal Sinus

Intervention

Procedure:
• NPWT for Pilonidal Surgery
After excision of pilonidal sinus Non powered-NPWT will be applied to the area
• Excision of Pilonidal sinus with normal dressing
After excision of pilonidal sinus normal dressing will be applied to the area of surgery

Locations

Country	Name	City	State
Ireland	Tallaght Hospital	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
The National Children's Hospital, Tallaght

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Wound size ratio	Healing as ratio of the initial wound	Wound size ratio will be recorded at 1 week to 6 weeks at weekly intervals
Secondary	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
Secondary	Recurrence	Recurrence of disease at 6 months from surgery	Patient will be assessed at 6 months from surgery
Secondary	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