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

NCT07855107 | Recruiting

• 1 other identifier: 2026PHB630
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pilonidal Sinus Disease

Keywords

VAAPS; Pilonidal Sinus

Outcome Measures

Primary Outcomes (3)

• 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.

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

• 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.

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

• 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.

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

Secondary Outcomes (3)

• Recurrence rate

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

• Patient Satisfaction Score (PSS)

  Postoperative months 3 and 12

• Cosmetic outcome assessed by Wound Evaluation Scale

  Postoperative month 6 and 12

Study Arms (1)

VAAPS with Loose Seton Drainage

EXPERIMENTAL

All enrolled participants receive the same intervention: video-assisted ablation of pilonidal sinus (VAAPS) with intraoperative placement of two loose glove-edge seton strips for postoperative drainage.

Procedure: VAAPS with Loose Seton Drainage

Interventions

VAAPS with Loose Seton Drainage PROCEDURE

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.

VAAPS with Loose Seton Drainage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Related Publications (13)

• Milone M, Di Minno MN, Bianco P, Coretti G, Musella M, Milone F. Pilonidal sinus surgery: could we predict postoperative complications? Int Wound J. 2016 Jun;13(3):349-53. doi: 10.1111/iwj.12310. Epub 2014 Jun 3.

  PMID: 24894163 RESULT

• Doll D. 5- and 10-year recurrence rate is the new gold standard in pilonidal sinus surgery benchmarking. Med Princ Pract. 2010;19(3):216-7. doi: 10.1159/000285292. Epub 2010 Mar 29. No abstract available.

  PMID: 20357506 RESULT

• Meinero P, Gasloli G, Giani F, et al. Endoscopic pilonidal sinus treatment: a multicentric prospective study. Tech Coloproctol. 2016;20(11):747-752.

  RESULT

• Sekhon Inderjit Singh HK, Meinero P, Campanile FC, Quddus A, Rajaganeshan R, Warusavitarne J, Dotlacil V, Bhargava A, Giordano P, Pini Prato A, Shatkar V, Jalali P, Halahakoon VC, Gallo G, Milone M, Mantoo S, Leo CA, Esposito C, Farghaly M, Arulampalam T, Pawa N. The application of EPSiT in pilonidal sinus disease: an international Delphi consensus study endorsed by the Association of Laparoscopic Surgeons of Great Britain and Ireland (ALSGBI). Tech Coloproctol. 2025 Jul 30;29(1):155. doi: 10.1007/s10151-025-03191-7.

  PMID: 40736584 RESULT

• Milone M, Velotti N, Manigrasso M, Vertaldi S, Di Lauro K, De Simone G, Cirillo V, Maione F, Gennarelli N, Sosa Fernandez LM, De Palma GD. Long-term results of a randomized clinical trial comparing endoscopic versus conventional treatment of pilonidal sinus. Int J Surg. 2020 Feb;74:81-85. doi: 10.1016/j.ijsu.2019.12.033. Epub 2020 Jan 9.

  PMID: 31926328 RESULT

• Milone M, Fernandez LM, Musella M, Milone F. Safety and Efficacy of Minimally Invasive Video-Assisted Ablation of Pilonidal Sinus: A Randomized Clinical Trial. JAMA Surg. 2016 Jun 1;151(6):547-53. doi: 10.1001/jamasurg.2015.5233.

  PMID: 26819186 RESULT

• Milone M, Musella M, Di Spiezio Sardo A, Bifulco G, Salvatore G, Sosa Fernandez LM, Bianco P, Zizolfi B, Nappi C, Milone F. Video-assisted ablation of pilonidal sinus: a new minimally invasive treatment--a pilot study. Surgery. 2014 Mar;155(3):562-6. doi: 10.1016/j.surg.2013.08.021. Epub 2013 Oct 25.

  PMID: 24300343 RESULT

• Al-Khamis A, McCallum I, King PM, Bruce J. Healing by primary versus secondary intention after surgical treatment for pilonidal sinus. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD006213. doi: 10.1002/14651858.CD006213.pub3.

  PMID: 20091589 RESULT

• Steele SR, Perry WB, Mills S, Buie WD; Standards Practice Task Force of the American Society of Colon and Rectal Surgeons. Practice parameters for the management of pilonidal disease. Dis Colon Rectum. 2013 Sep;56(9):1021-7. doi: 10.1097/DCR.0b013e31829d2616. No abstract available.

  PMID: 23929010 RESULT

• Enriquez-Navascues JM, Emparanza JI, Alkorta M, Placer C. Meta-analysis of randomized controlled trials comparing different techniques with primary closure for chronic pilonidal sinus. Tech Coloproctol. 2014 Oct;18(10):863-72. doi: 10.1007/s10151-014-1149-5. Epub 2014 Apr 30.

  PMID: 24845110 RESULT

• Allen-Mersh TG. Pilonidal sinus: finding the right track for treatment. Br J Surg. 1990 Feb;77(2):123-32. doi: 10.1002/bjs.1800770203.

  PMID: 2180534 RESULT

• Sondenaa K, Andersen E, Nesvik I, Soreide JA. Patient characteristics and symptoms in chronic pilonidal sinus disease. Int J Colorectal Dis. 1995;10(1):39-42. doi: 10.1007/BF00337585.

  PMID: 7745322 RESULT

• McCallum IJ, King PM, Bruce J. Healing by primary closure versus open healing after surgery for pilonidal sinus: systematic review and meta-analysis. BMJ. 2008 Apr 19;336(7649):868-71. doi: 10.1136/bmj.39517.808160.BE. Epub 2008 Apr 7.

  PMID: 18390914 RESULT

MeSH Terms

Conditions

Pilonidal Sinus

Condition Hierarchy (Ancestors)

Cysts; Neoplasms

Study Officials

• Bozhi Hu, M.D.

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bozhi Hu, M.D.

CONTACT

0086-18811783528; hbz0411@bjmu.edu.cn

Bozhi Hu, M.D.

CONTACT

0086-17812299283; hbz0411@pku.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: All enrolled participants receive the same intervention: video-assisted ablation of pilonidal sinus (VAAPS) with intraoperative placement of two loose glove-edge seton strips for postoperative drainage. There is no parallel control arm, randomization, or blinded treatment assignment. Outcome data are collected prospectively at predefined postoperative time points (day 1, weeks 1/2/4/6, months 3/6/12, and 36) to describe wound healing, pain, time off work, and recurrence in this patient population.

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2031
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)