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Primary Closure vs Open Technique for Pilonidal Sinus

NCT07311707 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-12-31

No results posted yet for this study

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

Interventions

PROCEDURE

Primary Suturing of Surgical Wound

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.

PROCEDURE

Open Surgical Wound Management

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

Sponsors & Collaborators

  • Khyber Teaching Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07311707 on ClinicalTrials.gov