Improving wound healing for complex pilonidal sinus disease with a new care pathway
Bascom Cleft Lift for Primary Wound Healing in Complex and Recurrent Sacrococcygeal Pilonidal Sinus Disease
Albert Schweitzer Ziekenhuis, Netherlands · NCT06683274
This study is testing a new care plan for people with complex pilonidal sinus disease to see if it helps them heal faster and get back to their normal activities better than the usual surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 58 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Albert Schweitzer Ziekenhuis, Netherlands (other) |
| Locations | 1 site (Dordrecht) |
| Trial ID | NCT06683274 on ClinicalTrials.gov |
What this trial studies
This observational study aims to enhance the treatment of patients suffering from complex or recurrent pilonidal sinus disease by establishing a best practice care pathway that includes a standardized cleft lift operation. The study will compare the effectiveness of this new approach against traditional excision techniques in terms of wound healing time and the duration required for patients to return to their normal activities. By implementing this standardized method, the researchers hope to provide better outcomes for patients undergoing surgical treatment for this condition.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 16 and older who have symptomatic complex or recurrent pilonidal sinus disease and are scheduled for surgical treatment.
Not a fit: Patients who are pregnant or unable to provide informed consent due to language barriers will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to faster recovery times and improved quality of life for patients with complex pilonidal sinus disease.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving surgical outcomes for pilonidal sinus disease.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Dordrecht
- Albert Schweitzer ziekenhuis — Dordrecht, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Robert Smeenk, MD, PhD — Albert Schweitzer Ziekenhuis, Netherlands
- Study coordinator: Max Goudberg, MD
- Email: m.r.goudberg@asz.nl
- Phone: +31622577653
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pilonidal Sinus, Pilonidal sinus, Bascom cleft lift