Pilonidal sinus care with VAAPS and loose seton drainage after VAAPS

Is this trial a fit for you?

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

What this trial studies

This is a single-center, prospective, single-arm cohort study evaluating VAAPS with a loose glove-edge seton drainage in adults with pilonidal sinus who cannot return for daily wound care. The intervention uses two improvised glove-edge rubber strips around the sinus openings to keep the tract open and allow home dressing changes at weeks 1 and 3 postoperatively. Eligible patients have sacrococcygeal pilonidal disease and are undergoing VAAPS, with ASA I-II and the ability to comply with follow-up. Outcomes focus on feasibility, wound healing, pain, infection, and recurrence, compared conceptually to standard VAAPS with daily wound care. The study builds on prior VAAPS data showing reduced recovery time and favorable patient-reported outcomes, adapting the technique to improve accessibility for out-of-town patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years
* Clinically diagnosed sacrococcygeal pilonidal sinus by physical examination and pelvic MRI
* Surgical indication for VAAPS procedure
* Unable to attend long-term postoperative wound care at the operating center (i.e., out-of-town patients who will return to their local residence for postoperative recovery)
* American Society of Anesthesiologists (ASA) physical status class I or II
* Able to understand and provide written informed consent
* Sufficient clinical records and ability to complete postoperative follow-up

Exclusion Criteria:

* Presence of an open sacrococcygeal wound or unhealed wound after incision and drainage that prevent VAAPS surgery.
* Severe cardiac, pulmonary, hepatic, renal, or other major organ dysfunction, or uncontrolled severe comorbidities
* Coagulation disorder or ongoing anticoagulation therapy
* Active infection, immunodeficiency disease, or autoimmune disease
* Pregnant or breastfeeding women
* Unable to comply with postoperative follow-up or unable to provide informed consent
* Other conditions precluding tolerance to general anesthesia or prone positioning

Where it's running

• Peking University People's Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Bozhi Hu, M.D. — Peking University People's Hospital
• Study coordinator: Bozhi Hu, M.D.
• Email: hbz0411@bjmu.edu.cn
• Phone: 0086-18811783528

Similar studies

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

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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.