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NCT Number: NCT07370714

Factors Affecting Wound Dehiscence in Pilonidal Sinus Surgery (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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Etlik City Hospital

Ankara, 06230, Turkey (Türkiye)

Location status: Recruiting

Location contact

Muhammed Salih Süer, Attendant

CONTACT

[email protected]

+905445943494

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Postoperative Wound Dehiscence

    Time frame: Within 30 days after surgery

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

Secondary outcomes

  1. Time to Complete Wound Healing

    Time frame: Up to 90 days after surgery

    Time from surgery to complete epithelialization of the surgical wound without discharge or need for additional intervention.

Study contacts

Contact information is provided by the study sponsor or research team.

Muhammed Salih Süer, Attendant

CONTACT

[email protected]

+905445943494

Sponsors and collaborators

Lead sponsor

Ankara Etlik City Hospital

Other Gov

Registry information

Official study title

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)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 27, 2026
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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