Clinical trial Recruiting at 1 site Observational Ages 16 and up

Improving wound healing for complex pilonidal sinus disease with a new care pathway

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

Run by Albert Schweitzer Ziekenhuis, Netherlands · NCT06683274 · Data updated 2026-11-12

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 typeObservational
Ages16 Years and up
SexAll
Enrollment58 (estimated)
SponsorAlbert Schweitzer Ziekenhuis, Netherlands
Academic / other
Locations1 site (Dordrecht)
StatusRecruiting
StartedFebruary 20, 2025
Main results expectedJanuary 2027
Study endsApril 2027
Registry record updatedSeptember 30, 2025
Trial IDNCT06683274 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably not a fit

Patients who are pregnant or unable to provide informed consent due to language barriers will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: While this approach is innovative, similar studies have shown promise in improving surgical outcomes for pilonidal sinus disease.

Who can join: the full rules

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 it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Sacral ESP Block to Help Pain After Pilonidal Sinus Surgery

    This study tests whether an ultrasound-guided sacral erector spinae plane (ESP) block after pilonidal sinus surgery can reduce pain and opioid use.

    Recruiting Medipol University · Istanbul · NCT07534488

  • Laser treatment with two-year follow-up for pilonidal cysts

    This project will see if laser surgery prevents pilonidal sinus recurrence within two years in adults who need the procedure.

    Recruiting at 2 sites Centre Hospitalier Departemental Vendee · Cornebarrieu and 1 other locations · NCT07314632

  • Wound care after pilonidal sinus surgery

    This study tests if a special wound treatment helps people heal better and feel happier after surgery for pilonidal sinus disease compared to regular wound care.

    Recruiting at 10 sites Royal College of Surgeons, Ireland · Castlebar and 9 other locations · NCT06647290

  • Testing a topical treatment for pilonidal disease

    This study is testing a new cream to see if it can help people with pilonidal disease feel better and reduce their symptoms.

    Recruiting Phase 2 University of Pennsylvania · Philadelphia, Pennsylvania · NCT06286397

  • Registry for soft tissue reconstruction using Myriad™ devices

    This study is testing how safe and effective Myriad Matrix™ and Morcells™ devices are for people undergoing soft tissue reconstruction surgeries for different conditions.

    Recruiting at 6 sites Aroa Biosurgery Limited · Phoenix, Arizona and 14 other locations · NCT05243966

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.