Bascom Cleft Lift for Primary Wound Healing in Complex and Recurrent Sacrococcygeal Pilonidal Sinus Disease

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorAlbert Schweitzer Ziekenhuis, Netherlands

About this trial

The goal of this observational study is to improve care for patients with complex or recurrent pilonidal sinus disease by developing and implementing a best practice care pathway, including a standardized cleft lift operation.

The main question it aims to answer is: Does a best practice care pathway with standardized cleft lift operation lead to shorter wound healing time and time to return to normal activities, compared to current standard care, with traditional excision techniques.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

16 years of age and older

Symptomatic complex or recurrent pilonidal sinus disease

Planned for surgical treatment

Signed informed consent

Disqualifiers

Pregnant

Insufficient understanding of the Dutch language or otherwise unable to give consent

Trial population

Patients with (symptomatic) complex or recurrent pilonidal sinus disease, who will be planned for surgical treatment.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

58 Participants
are grouped into 2 trial groups
Group A: Control cohort
Group B: Interventional cohort

Trial outcomes

Primary outcomes

1

Wound healing time

Time to wound healing (in days), this will be self reported by patients when the skin is completely closed, and will be validated through clinical assessment by the surgeon.

Time frame
The outcome will be evaluated at each follow-up visit, at 1-3 weeks, 4-6 weeks and 6 months postoperative. If necessary, additional visits will be planned

Secondary outcomes

1

Return to normal activities

Time to return to normal activities after surgery (in days). This will be self reported by patients through a brief checklist on which the activities (washing, dressing, sitting, work/study) should be checked when possible without discomfort.

Time frame
The outcome will be evaluated at each follow-up visit, at 1-3 weeks, 4-6 weeks and 6 months postoperative. If necessary, additional visits will be planned

Other outcomes

1

Quality of Life

Quality of Life, measured with EuroQol 5 dimensions, 5 levels (EQ-5D-5L) questionnaire. The questions are answered on a 5 point Likert scale. Ranging from 5-25, with 5 being the best possible outcome and 25 being the worst possible outcome. Additionally, there is a general question on a 0-100 scale, with 0 being the worst health possible and 100 being the best health possible.

Time frame
Baseline, 4-6 weeks and 6 months postoperative.
2

Pain

Pain score, on a Numeric Rating Scale ranging from 0-10 with 0 representing 'no pain' and 10 representing 'the worst pain possible'

Time frame
The outcome will be evaluated at each follow-up visit, at 1-3 weeks, 4-6 weeks and 6 months postoperative.

Sponsors and contacts

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