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NCT07855107
VAAPS Combined With Loose Seton Drainage for Postoperative Self-Care: A Prospective Single-Arm Cohort Study
Conditions: Pilonidal Sinus Disease
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: Peking University People's Hospital
Location: Peking University People's Hospital Beijing Beijing Municipality
Summary
Pilonidal sinus is a chronic infection of the sacrococcygeal skin that mainly affects young adults. Traditional surgery leaves large wounds requiring weeks of daily dressing changes away from home. Video-Assisted Ablation of Pilonidal Sinus (VAAPS) is a minimally invasive procedure that leaves only a 7-mm wound, but it requires daily saline flushing of the sinus tract and regular follow-up at the operating center. At Peking University People's Hospital, over 60% of VAAPS patients travel from other provinces and cannot return for standardized daily wound care. To address this, we developed a loose glove-edge seton technique: two rubber strips cut from surgical glove edges are loosely tied around the sinus openings during surgery to keep them patent, allowing normal dressing changes at home without flushing. The first strip is removed at 1 week and the second at 3 weeks postoperatively. This is a single-center prospective observational study of 50 out-of-town patients undergoing VAAPS with this seton technique. We will collect pain scores, time off work, wound healing time, complications, and recurrence over 3 years to assess whether self-care after VAAPS with loose seton is safe, effective, and feasible for patients who cannot return to the operating center for routine care.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07855107). StuddyBuddy aggregates publicly available trial information.