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

The National Children's Hospital, Tallaght

Status: Unknown

Conditions: Pilonidal Disease; Pilonidal Sinus

Treatments: Procedure: Excision of Pilonidal sinus with normal dressing; Procedure: NPWT for Pilonidal Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03483480

2018-02

Details and patient eligibility

About

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

Non powered-NPWT

Experimental group

Treatment:

Procedure: NPWT for Pilonidal Surgery

Open Technique

Active Comparator group

Treatment:

Procedure: Excision of Pilonidal sinus with normal dressing