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

NCT ID: NCT06683274

Last Updated: 2025-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

58 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-20

Study Completion Date

2027-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pilonidal Sinus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control cohort

Current practice cohort

No interventions assigned to this group

Interventional cohort

Best practice care pathway with standardized Bascom cleft lift

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 16 years of age and older
* Symptomatic complex or recurrent pilonidal sinus disease
* Planned for surgical treatment
* Signed informed consent

Exclusion Criteria

* Pregnant
* Insufficient understanding of the Dutch language or otherwise unable to give consent
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Albert Schweitzer Ziekenhuis, Netherlands

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Max Goudberg

MD, PhD candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Robert Smeenk, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Albert Schweitzer Ziekenhuis, Netherlands

Boudewijn Toorenvliet, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ikazia ziekenhuis

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Albert Schweitzer ziekenhuis

Dordrecht, , Netherlands

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Max Goudberg, MD

Role: CONTACT

+31622577653

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Max Goudberg

Role: primary

+31622577653

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2024.077

Identifier Type: OTHER

Identifier Source: secondary_id

2024.077

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.