post operative negatieve pressure therapy after pilonidal sinus excision.

The biggest problem of pilonidal sinus surgery with secondary wound healing is
the long time it takes to heal the wounds.
The population of patients is young and active and the place of the wound is
annoying. The healing of the wound is slow and therefore the patient can not
work or go to school for a long time. The woundmanagement with standard
bandages is considerd to be difficult by the patients.
Because we have good results with negative pressure wound therapy and we think
that especially this population has benefit of a quick healing result, we
designed this study.

If negative pressure wound therapy reduces the period of wound healing with 2
weeks till 6 weeks, instead of 8 weeks ( all are approximate values), it can be
the standard therapy in the future.

It is a prospective randomized trial (1:1). The diagram shows the following
steps( attachment 1)

All adult patients have to read teh information form and sign the approvel
form. If the patient has the correct criteria the history and fysical exam is
performed by the physcian and written down on the intake form.

The randomisation is centralized and takes place after consulting the study
director.

Both study groups get the same surgery only the type of woundmanagment differs
in the first two weeks.

The wound is measured, the name of the surgeons is written down and
complications are documented on the operation form. The same form is used to
determine the hospital stay and possible other complications during stay.

The first 2 weeks the patient is controlled twice in the hospital by the
physician (day 7 and 14) and/or the wound nurse (day 3, 7, 10, 14). In case of
negative pressure wound therapy the wound nurse changes the wounddressing. All
the findings like wound measurements and pain score are written down on the
control form. The negative pressure wound therapy ends on day 14, from that
moment both groups are treated the same.
14 days of negative pressure wound therapy is based on literature findings and
is considered to be an acceptabel period for the patient. After this period the
activity of the patients grows so even the portable system we use can be
annoying.

After 14 days the patient is seen weekly by the physician till the wound has
healed. The last planned visit is after 6 months to check for recurrence.

vacuum wound therapy for 2 weeks.

We expect minimal extra burden or risk with this treatment based on literature
and our own findings in the clinic. This is futher explained in the study
protocol.

A faster woundhealing, like we observed in the clinic, is only a benefit for
this patient group.