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Background

Pilonidal sinus disease (PSD) is a condition that usually affects the skin just at the top of the buttocks near the tailbone. It is a chronic condition characterised by a small hole, tunnel (sinus), or pocket (cyst) that develops in the skin. These usually contain hair, dead skin, and debris and can often become infected. Infection will cause pain and swelling in the tailbone area, and a pus-filled skin abscess can develop.

PSD is a common condition that is on the rise. Young, working people are also more likely to be affected. It can be disruptive to the patient’s job, social life, and overall well-being. 

The cure for PSD usually requires surgery, but doctors use several different methods, and it's unknown which one is the best. Some of these operations try to keep the surgery to a minimum, allowing quicker recovery. The study will focus on these types of operations.

Current treatment

There are two main surgical approaches: One involves removing the affected skin and closing the wound. The other one aims to save the skin by using so-called minimally invasive surgery (MIS). The most appropriate treatment depends on the type and severity of the disease. In some cases, a skin-removing operation may be the safest and most effective option. For patients who are suitable for minimally invasive surgery, several different procedures can be used. At the moment, we do not know whether one minimally invasive procedure is better than the others.

Aim of the study

The main aim of this trial is to identify whether pit-picking and glue is a clinically and cost-effective treatment for pilonidal sinus disease, compared to other routinely undertaken minimally invasive operations.

This means:

• To compare whether pit picking + glue results in a significantly faster time to return to normal activities than other minimally invasive interventions for PSD.

• To compare whether pit picking + glue results in a similar treatment failure rate to other minimally invasive interventions for PSD.

• To compare outcomes after stratifying into non-complex (non-recurrent disease with pits or sinuses confined to the midline) and complex disease (midline disease with secondary sinus/es or abscess scar/s or any disease after treatment with definitive intent).

Methods

This is a multicentre, double-blind, randomised superiority and non-inferiority controlled trial with a minimum of six-month follow-up.

The study will take place in 40 hospitals across the UK. 610 people with pilonidal sinus disease will be put into one of two groups by chance:

1. One group will have a type of surgery called pit-picking with glue. The tiny pits that result from the ingrowing hairs are simply removed, and the underlying infected cavity is cleaned out. The cavity is then filled with a special glue.
2. The other group will have a different type of surgery chosen by their doctor. However, this surgery will also be minimal, allowing for a quick recovery. All operations are part of usual care in the NHS.

The study builds on the NIHR-funded PITSTOP trial.

Central Study Staff

Co-Applicants

Funder

This project is funded by the National Institute for Health Research, Health Technology Assessment (NIHR HTA) Programme (NIHR175072).

Research governance sponsor

Sheffield Teaching Hospitals NHS Foundation Trust.