Primary Closure vs Open Technique for Pilonidal Sinus (NCT07311707) | Clinical Trial Compass
CompletedNot Applicable
Primary Closure vs Open Technique for Pilonidal Sinus
Pakistan60 participantsStarted 2023-07-01
Plain-language 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.
Who can participate
Age range
20 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compared primary closure versus leaving the wound open after pilonidal sinus surgery — based on what this study found about healing times, which approach does my doctor think would be better for my specific situation?
2Since this trial is now completed and was measuring mean duration of wound healing, has the data been published yet, and can my doctor share what the results showed about how long recovery took for each surgical technique?
3Given that pilonidal sinus can involve a chronic infected sinus tract, how does the presence or severity of infection in my case affect which surgical technique — open or closed — my doctor would recommend?
4This trial was categorized as Phase NA, meaning it was comparing existing surgical approaches rather than testing a new drug or device — does my doctor already have a preferred technique based on their own experience, and how does that align with what this study found?
5Are there factors in my daily life, like how much time I can take off work or my ability to manage wound care at home, that should influence whether an open or closed closure approach makes more sense for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.