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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)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07370714
Enrollment
250
Registered
2026-01-27
Start date
2025-12-01
Completion date
2026-12-01
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pilonidal Sinus Disorder

Keywords

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

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.

Interventions

OTHERNo 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.

Sponsors

Ankara Etlik City Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Wound DehiscenceWithin 30 days after surgeryWound dehiscence is defined as partial or complete separation of the surgical wound occurring after pilonidal sinus surgery, as assessed during postoperative follow-up.

Secondary

MeasureTime frameDescription
Time to Complete Wound HealingUp to 90 days after surgeryTime from surgery to complete epithelialization of the surgical wound without discharge or need for additional intervention.

Countries

Turkey (Türkiye)

Contacts

CONTACTMuhammed Salih Süer, Attendant
suersalih@gmail.com+905445943494

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026