Comparison of Primary Closure Vs Open Wound in Pilonidal Sinus Excision.

Comparison of Wound Infection in Patients Undergoing Primary Closure and Open Technique in The Treatment of Pilonidal Sinus.

The goal of this randomized clinical trial is to compare wound infection rates after two surgical techniques for treating pilonidal sinus in adults.

The main question this study aims to answer is:

Is wound infection less common after primary closure than after the open technique? Researchers will compare patients who receive primary closure with patients who receive the open technique after removal of the pilonidal sinus. The study will include 68 men and women between 18 and 75 years of age. Participants will be randomly assigned to one of the two treatment groups.

Participants will:

Undergo surgery using either primary closure or the open technique. Attend follow-up visits after surgery. Have the surgical wound examined 7 days after the procedure. Provide information about their health, medical history, and recovery. The study will record whether participants develop wound infection, including swelling, redness, or pus or clear fluid coming from the wound. The study will be conducted in the General Surgery Department at Medical Institute Haytabad Medical Complex, Peshawar.

Study Overview

• Status: Completed
• Conditions: Wound Infection; Pilonidal Sinus Treatment; Sacrococcygeal Pilonidal Sinus; Primary Closure
• Intervention / Treatment: Procedure: Primary Closure Technique; Procedure: Open Technique

Detailed Description

Detailed Description

Pilonidal sinus is a chronic condition involving the skin and subcutaneous tissue in the sacrococcygeal or natal cleft region. It commonly presents with one or more midline openings, local pain, redness, swelling, or discharge. Surgical treatment is frequently required for symptomatic disease. However, the most appropriate method of wound management after excision remains uncertain. Primary closure may allow faster wound healing and reduce the period of open wound care, whereas the open technique may reduce tension on the wound but requires healing by secondary intention and regular dressing care.

This randomized controlled trial will compare two surgical approaches for the treatment of pilonidal sinus: primary closure and open healing. The study will be conducted in the General Surgery Department of Hayatabad Medical COmplex, Peshawar, after approval from the relevant institutional ethical review board and the research department of the College of Physicians and Surgeons Pakistan, Karachi.

Eligible participants who provide written informed consent will be assigned to one of two treatment groups using blocked randomization:

Group A: Excision of the pilonidal sinus followed by primary closure. Group B: Excision of the pilonidal sinus followed by open wound management and healing by secondary intention.

Before surgery, the research team will record relevant demographic and clinical information. Participants will undergo a clinical examination and routine preoperative assessment according to institutional practice. The surgical procedures will be performed under appropriate anesthesia by, or under the supervision of, a qualified general surgeon.

For participants in Group A, the sinus and surrounding diseased tissue will be excised down to the level of the sacral fascia. Any secondary tracts identified during surgery will also be removed. After achieving hemostasis, the wound will be closed in layers using polypropylene sutures. The closure will include approximation of the deeper tissues and skin. A suction drain may be placed when clinically indicated. The wound will then be covered with an appropriate sterile dressing.

For participants in Group B, the sinus and surrounding diseased tissue will be excised down to the sacral fascia. After hemostasis, the resulting cavity will be packed with povidone-iodine-soaked gauze. The initial packing will be removed approximately 48 hours after surgery. The wound will then remain open and will be managed with regular dressings until healing is complete. Participants in this group will attend outpatient follow-up visits, generally on a weekly basis or as clinically required.

Participants in both groups will receive postoperative care according to the hospital's standard practice. This may include analgesics, wound-care instructions, advice regarding hygiene, and instructions to return to the hospital if they develop worsening pain, fever, swelling, redness, or discharge. Follow-up assessment will be performed by the research team under the supervision of a consultant surgeon.

Information collected during the study will be recorded on a structured data-collection proforma. Each participant will be assigned a study identification number. Personal information will be kept confidential and will be accessed only by authorized members of the research team. The study findings will be analyzed to compare the postoperative wound outcomes of the two surgical techniques.

The study is intended to provide local clinical evidence regarding the choice between primary closure and open wound management after pilonidal sinus excision. The findings may help surgeons and healthcare professionals make evidence-based decisions about postoperative management and patient counseling.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • KPK
    • Peshawar, KPK, Pakistan, 25000
      • Hayatabad Medical Complex, Peshawar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

INCLUSION CRITERIA:

• Male &Female
• Age between (18-75) Years
• Patients with pilonidal sinus as defined in the operational definition.

EXCLUSION CRITERIA:

• Patients with debilitating disease
• Patients with immunocompromised state like malignancy, and tuberculosis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Primary Closure Technique; Patients undergo excision of the pilonidal sinus and surrounding tissue down to the sacral fascia, followed by closure with polypropylene sutures. A suction drain (Radivac system) is placed, and vertical mattress sutures are used to approximate skin and subcutaneous tissue.	Procedure: Primary Closure Technique; Excision of sinus tract with closure using Prolene sutures and placement of suction drain.; Other Names: Primary Closure
Active Comparator: Open Technique; Patients undergo excision of the pilonidal sinus with surrounding tissue down to sacral fascia. The wound is left open and packed with pyodine-soaked gauze. Patients return for weekly outpatient follow-up until complete healing.	Procedure: Open Technique; Excision of sinus tract with open wound packing and secondary healing.; Other Names: Surgical excision with open wound management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound Infection	Frequency of wound infection within 30 days post-surgery	From surgery to 30 days post-operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound healing time	Healing assessed weekly until closure.	From date of Surgery until 90 days.
Surgery time	Duration of intervention recorded in minutes.	During surgical procedure.

Collaborators and Investigators

• Sponsor: Hayatabad Medical Complex

Publications and helpful links

General Publications

• Jabbar MS, Bhutta MM, Puri N. Comparison between primary closure with Limberg Flap versus open procedure in treatment of pilonidal sinus, in terms of frequency of post-operative wound infection. Pak J Med Sci. 2018 Jan-Feb;34(1):49-53. doi: 10.12669/pjms.341.13929.
• Kober MM, Alapati U, Khachemoune A. Treatment options for pilonidal sinus. Cutis. 2018 Oct;102(4):E23-E29.
• Iesalnieks I, Ommer A. The Management of Pilonidal Sinus. Dtsch Arztebl Int. 2019 Jan 7;116(1-2):12-21. doi: 10.3238/arztebl.2019.0012.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Actual): August 5, 2026
• Study Completion (Actual): August 10, 2026

Study Registration Dates

• First Submitted: August 21, 2026
• First Submitted That Met QC Criteria: August 29, 2026
• First Posted (Actual): September 1, 2026

Study Record Updates

• Last Update Posted (Actual): September 1, 2026
• Last Update Submitted That Met QC Criteria: August 29, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Wound Infection; pilonidal sinus; Sacrococcygeal pilonidal sinus; Pilonidal sinus Treatment; Primary Closure flaps; Pilonidal Sinus Infections
• Additional Relevant MeSH Terms: Neoplasms; Infections; Cysts; Wound Infection; Pilonidal Sinus; Surgical Procedures, Operative; Wound Closure Techniques; Abdominal Wound Closure Techniques; Open Abdomen Techniques
• Other Study ID Numbers: RMI_QAD_RCT_PILONOIDAL_sINUS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified participant data (demographics, wound infection outcomes, healing times) will be shared upon reasonable request to the principal investigator after study completion. Access will be granted to qualified researchers for academic purposes only.
• IPD Sharing Time Frame: IPD and supporting information will be available beginning 6 months after publication of primary results and remain accessible for 5 years.
• IPD Sharing Access Criteria: Qualified researchers with a methodologically sound proposal may request access. Requests will be reviewed by the principal investigator. Data will be shared through secure institutional data repositories upon approval.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No