Pilonidal SinusBATCRACNCT06683274
Bascom Cleft Lift for Primary Wound Healing in Complex and Recurrent Sacrococcygeal Pilonidal Sinus Disease
An observational study of Pilonidal Sinus, run by Albert Schweitzer Ziekenhuis, Netherlands at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Pilonidal Sinus
- How many people
- 58 participants
- Where
- 1 siteNetherlands
- Study dates
- 20 Feb 2025to Apr 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with (symptomatic) complex or recurrent pilonidal sinus disease, who will be planned for surgical treatment.
Who may be able to join
- 16 years of age and older
- Symptomatic complex or recurrent pilonidal sinus disease
- Planned for surgical treatment
- Signed informed consent
Who cannot join
- Pregnant
- Insufficient understanding of the Dutch language or otherwise unable to give consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Albert Schweitzer ziekenhuis
Dordrecht, 3318AT
Max Goudberg, +31622577653, m.r.goudberg@asz.nl
About this study
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.
- Conditions
- Pilonidal Sinus
- Keywords
- Pilonidal sinus, Bascom cleft lift
- Medical subject headings
- Pilonidal Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control cohort | Current practice cohort | |
| Interventional cohort | Best practice care pathway with standardized Bascom cleft lift |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start20 Feb 2025
- Primary completionJan 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pilonidal SinusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 58 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Albert Schweitzer Ziekenhuis, Netherlands
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Max Goudberg, Albert Schweitzer Ziekenhuis, Netherlands
- Investigators
- Robert Smeenk, MD, PhD, Principal investigator, Albert Schweitzer Ziekenhuis, NetherlandsBoudewijn Toorenvliet, MD, PhD, Principal investigator, Ikazia ziekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06683274
- Sponsor's protocol ID
- 2024.077
- Other IDs
- 2024.077
- Acronym
- BATCRAC
- Status last verified
- Sep 2025
- First submitted
- 7 Nov 2024
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bascom Cleft Lift for Primary Wound Healing in Complex and Recurrent Sacrococcygeal Pilonidal Sinus Disease
- ClinicalTrials.gov ID
- NCT06683274
- Acronym / sponsor ID
- BATCRAC / 2024.077
- Conditions
- Pilonidal Sinus
- Keywords
- Pilonidal sinus, Bascom cleft lift
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Albert Schweitzer Ziekenhuis, NetherlandsUniversity, hospital or other
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control cohort | – | –Current practice cohort |
| Interventional cohort | – | –Best practice care pathway with standardized Bascom cleft lift |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with (symptomatic) complex or recurrent pilonidal sinus disease, who will be planned for surgical treatment.
Key inclusion criteria (4 listed)
- 16 years of age and older
- Symptomatic complex or recurrent pilonidal sinus disease
- Planned for surgical treatment
- Signed informed consent
Key exclusion criteria (2 listed)
- Pregnant
- Insufficient understanding of the Dutch language or otherwise unable to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Wound healing time
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
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.
1 secondary outcome
Return to normal activities
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Smeenk, MD, PhD principal investigator
Albert Schweitzer Ziekenhuis, Netherlands
Boudewijn Toorenvliet, MD, PhD principal investigator
Ikazia ziekenhuis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pilonidal Sinus, run by Albert Schweitzer Ziekenhuis, Netherlands at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Max Goudberg, MD (+31622577653, m.r.goudberg@asz.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing time (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.