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VAAPS Combined With Loose Seton Drainage for Postoperative Self-Care: A Prospective Single-Arm Cohort Study

RecruitingNAAges 18 Years - anyAllPeking University People's Hospital
NCT07855107 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. Th

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📋 Eligibility rules (as published)
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
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What it tests

  • VAAPS with Loose Seton Drainage
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Where

1 site
Peking University People's Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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