Factors Affecting Wound Dehiscence in Pilonidal Sinus Surgery (ORIPIS)
ConditionPilonidal Sinus Disorder
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAnkara Etlik City Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients undergoing emergency surgery
Previous pilonidal sinus surgery at the same site
Inability to complete postoperative follow-up
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No intervention (observational study)
Other interventionThis 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.
Treatment groups
250 Participants
are divided into 1 treatment groupGroup A: Pilonidal Sinus Surgery Patients1 intervention
Trial outcomes
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.
Time frame
Within 30 days after surgerySecondary outcomes
1
Time to Complete Wound Healing
Time from surgery to complete epithelialization of the surgical wound without discharge or need for additional intervention.
Time frame
Up to 90 days after surgerySponsors and contacts
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Source ClinicalTrials.gov