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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University People's Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • VAAPS with Loose Seton Drainage

    Procedure/Surgery

    Video-assisted ablation of pilonidal sinus (VAAPS) is performed through the external sinus opening using a sinusoscope to identify side tracts, remove hair, and ablate the tract wall under direct vision, leaving a wound approximately 5 mm wide. At the completion of the procedure, two thin strips cut from sterile surgical glove edges are loosely looped around the upper and lower sinus openings and secured to the surrounding skin to maintain tract patency. No postoperative saline flushing is required. Patients perform routine dressing changes at a local clinic or at home. The first seton strip is removed at approximately 1 week postoperatively, and the second strip is removed at approximately 3 weeks. This loose seton technique prevents premature wound closure and fluid accumulation while allowing granulation tissue to grow from the tract base.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: VAAPS with Loose Seton DrainageExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Time off work after surgery

Number of days from the date of surgery until the patient returns to normal work or study. Recovery to work is defined as daily activities without significant limitation: no pain at rest or with activity, no pain while walking or sitting, and self-dressing changes no more than twice per day. This measures the primary short-term functional outcome of postoperative self-care after VAAPS combined with loose seton drainage.

Time frame
From surgery date until return to normal work or study(assessed at postoperative day 1, weeks 1, 2, 4, 6).
2

Time to complete wound healing after surgery

Number of days from the date of surgery until the surgical wound is completely epithelialized with no discharge, as assessed by a trained surgeon at follow-up visits. Delayed healing is defined as incomplete healing beyond 6 weeks postoperatively. This measures whether the loose seton technique achieves adequate wound healing in patients performing self-care or local dressing changes without standardized flushing at the operating center.

Time frame
From surgery date until complete wound epithelialization (assessed at postoperative weeks 1, 2, 4, 6, and months 3, 6).
3

Postoperative pain score (VAS) after surgery

Pain assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Patients rate their pain at multiple postoperative time points. Repeated-measures analysis describes the pain trajectory over the early postoperative period. This measures whether the loose seton technique and minimally invasive VAAPS produce tolerable pain during self-care at home.

Time frame
Postoperative 6 hours, day 1, week 1, week 2, week 4, and week 6

Secondary outcomes

1

Recurrence rate

Recurrence is defined as the appearance of at least one of the following after complete wound healing: physician-diagnosed recurrence, formation of a new sinus tract on examination or imaging, new external openings with hair or purulent discharge, or need for reoperation for recurrent local infection. Recurrence-free survival is estimated using the Kaplan-Meier method. Patients without recurrence at last follow-up are censored at the last follow-up date.

Time frame
Postoperative months 3, 6, 12, and 36 (1-year and 3-year recurrence rates reported)
2

Patient Satisfaction Score (PSS)

Overall patient satisfaction with the surgical outcome is self-reported using the Patient Satisfaction Score (PSS), ranging from 0 (completely dissatisfied) to 10 (completely satisfied). This captures patient-reported experience of the minimally invasive procedure and the feasibility of postoperative self-care at home.

Time frame
Postoperative months 3 and 12
3

Cosmetic outcome assessed by Wound Evaluation Scale

Cosmetic outcome of the sacrococcygeal wound is assessed using the Wound Evaluation Scale (WES), a standardized scoring system that evaluates scar appearance including width, contour, color match, and overall cosmetic appearance. A trained clinician rates the scar at the postoperative follow-up visit.

Time frame
Postoperative month 6 and 12

Other outcomes

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