Factors Affecting Wound Dehiscence in Pilonidal Sinus Surgery (ORIPIS)

NCT07370714 | Recruiting

• 1 other identifier: AEŞH-EK-2025-290
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this multicenter, prospective, observational study is to investigate factors associated with wound dehiscence following pilonidal sinus surgery. The main questions it aims to answer are: Does the proximity of the pilonidal sinus to the anal verge influence the risk of postoperative wound dehiscence? How do the morphological stage of the disease and the surgical technique used affect wound healing outcomes? Patients undergoing pilonidal sinus surgery as part of routine clinical care will be enrolled prospectively across multiple centers. Clinical, anatomical, and surgical characteristics-including anal proximity, morphological stage, and type of surgical technique-will be recorded. Participants will be followed postoperatively, and wound outcomes will be assessed to identify factors associated with wound dehiscence.

Conditions

Pilonidal Sinus Disorder

Keywords

pilonidal sinus; risk factors; surgical wound dehiscence; Surgical Closure Technique

Outcome Measures

Primary Outcomes (1)

• Postoperative Wound Dehiscence

  Wound dehiscence is defined as partial or complete separation of the surgical wound occurring after pilonidal sinus surgery, as assessed during postoperative follow-up.

  Within 30 days after surgery

Secondary Outcomes (1)

• Time to Complete Wound Healing

  Up to 90 days after surgery

Study Arms (1)

Pilonidal Sinus Surgery Patients

This cohort includes adult patients undergoing pilonidal sinus surgery as part of routine clinical care at participating centers. The study is observational in nature, and no experimental intervention is assigned. Surgical technique, anatomical characteristics including proximity to the anal verge, and morphological stage of the disease are determined by the treating surgeon according to standard practice. Patients are prospectively followed after surgery, and postoperative wound outcomes are recorded for observational analysis.

Other: No intervention (observational study)

Interventions

No intervention (observational study) OTHER

This is an observational study. No experimental intervention is assigned. Surgical procedures are performed as part of routine clinical care according to standard practice and are not determined by the study protocol.

Pilonidal Sinus Surgery Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients diagnosed with pilonidal sinus disease who undergo pilonidal sinus surgery as part of routine clinical care at participating centers. Eligible patients are enrolled prospectively and followed after surgery. Demographic, anatomical, and surgical characteristics are recorded for observational analysis of postoperative wound outcomes.

You may qualify if:

• Adult patients (≥18 years of age)
• Diagnosis of pilonidal sinus disease
• Patients undergoing pilonidal sinus surgery as part of routine clinical care
• Ability to provide informed consent

You may not qualify if:

• Patients undergoing emergency surgery
• Previous pilonidal sinus surgery at the same site
• Inability to complete postoperative follow-up

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Ankara, 06230, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pilonidal Sinus; Surgical Wound Dehiscence

Interventions

Observation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Muhammed Salih Süer, Attendant

CONTACT

+905445943494; suersalih@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 27, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)