Clinical trial · Interventional
Primary Closure vs Open Technique for Pilonidal Sinus
A Randomized Controlled Trial Comparing Primary Closure Versus Open Surgical Technique in the Management of Pilonidal Sinus Disease
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this randomized controlled trial is to compare two commonly used surgical techniques for the treatment of pilonidal sinus disease: excision with primary closure and excision with open (lay-open) technique. Pilonidal sinus disease is a chronic inflammatory condition of the natal cleft that causes pain, discharge, and functional discomfort, particularly in young adults. The primary aim of the study is to evaluate whether excision followed by primary closure leads to faster wound healing compared to the open surgical technique. Secondary aims include comparing postoperative wound infection and recurrence rates between the two surgical approaches. Eligible participants aged 20 to 50 years with uncomplicated pilonidal sinus disease will be randomly allocated to one of two treatment groups. All surgical procedures will be performed by an experienced surgical team at Khyber Teaching Hospital, Peshawar. Postoperative care and follow-up schedules will be standardized for all participants. Outcomes will be assessed during follow-up visits at 1 week, 3 weeks, and 12 weeks after surgery. This study is intended to provide evidence to guide surgical decision-making and improve postoperative outcomes for patients with pilonidal sinus disease.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Infected Sinus Tract | — | UNRESOLVED | — |
| Pilonidal Sinus Disease | — | UNRESOLVED | — |
| Post-surgical Wound Healing | — | UNRESOLVED | — |
| Sacrococcygeal Pilonidal Sinus | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Open Surgical Wound Management | Procedure | — | UNRESOLVED |
| Primary Suturing of Surgical Wound | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Excision with Primary Closure
- description
- Participants assigned to this arm will undergo complete surgical excision of the pilonidal sinus tract followed by primary closure of the wound using standard suturing techniques. All procedures will be performed by an experienced surgical team. Postoperative management will be standardized and will include routine wound care, sitz baths, and antibiotic prophylaxis according to institutional protocol. Participants will be followed postoperatively to assess wound healing progress, postoperative complications, and recurrence during scheduled follow-up visits.
- interventionNames
- Procedure: Primary Suturing of Surgical Wound
- Procedure: Open Surgical Wound Management
- type
- EXPERIMENTAL
- label
- Excision with Open (Lay-Open) Technique
- description
- Participants assigned to this arm will undergo complete surgical excision of the pilonidal sinus tract, with the wound left open to heal by secondary intention. Standard postoperative wound care will be provided, including regular dressings, sitz baths, and antibiotic prophylaxis according to institutional protocol. Participants will be monitored during follow-up visits to assess wound healing, postoperative complications, and recurrence.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Male and female patients aged 20 to 50 years. Clinically diagnosed with pilonidal sinus (persistent painful discharging wound in the buttock cleft for more than eight weeks, VAS \>4). Patients willing to provide written informed consent. Exclusion Criteria: * Pilonidal sinus located away from the midline coccyx. Presence of abscess formation. Patients with underlying conditions affecting wound healing (e.g., diabetes mellitus). Recurrent pilonidal sinus.
References
Publications (0)
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