Primary Closure vs Open Technique for Pilonidal Sinus

NCT07311707 | Completed

• 1 other identifier: 153/DME/KMC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Pilonidal Sinus Disease; Sacrococcygeal Pilonidal Sinus; Chronic Infected Sinus Tract; Post-surgical Wound Healing

Keywords

Pilonidal Sinus; Primary Closure; Wound Healing; Randomized Controlled Trial; Surgical Site Infection

Outcome Measures

Primary Outcomes (1)

• Mean Duration of Wound Healing After Surgery

  Time (in days) from surgical intervention to complete wound epithelialization, assessed at 1, 3, and 12 weeks postoperatively, comparing primary closure versus open surgical technique.

  12 weeks

Study Arms (2)

Excision with Primary Closure

EXPERIMENTAL

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.

Procedure: Primary Suturing of Surgical Wound; Procedure: Open Surgical Wound Management

Excision with Open (Lay-Open) Technique

EXPERIMENTAL

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.

Procedure: Primary Suturing of Surgical Wound; Procedure: Open Surgical Wound Management

Interventions

Primary Suturing of Surgical Wound PROCEDURE

The surgical site will be closed immediately after surgery using standard suturing techniques to approximate wound edges. This is the conventional method for wound closure in this study.

Excision with Open (Lay-Open) Technique; Excision with Primary Closure

Open Surgical Wound Management PROCEDURE

The surgical site will be managed using an open approach without primary closure, with standard postoperative wound care.

Excision with Open (Lay-Open) Technique; Excision with Primary Closure

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Khyber Teaching Hospital: lead

Study Sites (1)

Wasim Khan

Peshawar, 25000, Pakistan

Location

MeSH Terms

Conditions

Pilonidal Sinus; Surgical Wound Infection

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: December 31, 2025
• Study Start: July 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)