Factors Affecting Wound Dehiscence in Pilonidal Sinus Surgery (ORIPIS)

A Multicenter, Prospective, Observational Study on Factors Affecting Wound Dehiscence in Pilonidal Sinus Surgery: The Impact of Anal Proximity, Morphological Stage, and Surgical Technique (ORIPIS)

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.

Study Overview

• Status: Recruiting
• Conditions: Pilonidal Sinus Disorder
• Intervention / Treatment: Other: No intervention (observational study)

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Muhammed Salih Süer, Attendant; Phone Number: +905445943494; Email: suersalih@gmail.com

Study Locations

• Turkey (Türkiye)
  • Ankara
    • Ankara, Ankara, Turkey (Türkiye), 06230
      • Recruiting
      • Ankara Etlik City Hospital
      • Contact: Muhammed Salih Süer, Attendant; Phone Number: +905445943494; Email: suersalih@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Complete Wound Healing	Time from surgery to complete epithelialization of the surgical wound without discharge or need for additional intervention.	Up to 90 days after surgery

Collaborators and Investigators

• Sponsor: Ankara Etlik City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 23, 2025
• First Submitted That Met QC Criteria: January 21, 2026
• First Posted (Actual): January 27, 2026

Study Record Updates

• Last Update Posted (Actual): January 27, 2026
• Last Update Submitted That Met QC Criteria: January 21, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: risk factors; surgical wound dehiscence; pilonidal sinus; Surgical Closure Technique
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Neoplasms; Cysts; Pathological Conditions, Signs and Symptoms; Surgical Wound Dehiscence; Pilonidal Sinus; Investigative Techniques; Methods; Observation
• Other Study ID Numbers: AEŞH-EK-2025-290

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be made publicly available. De-identified data may be shared for scientific purposes upon reasonable request, in accordance with institutional policies and ethics committee approval.