Pilonidal Sinus DisorderNCT07370714
Factors Affecting Wound Dehiscence in Pilonidal Sinus Surgery (ORIPIS)
An observational study of Pilonidal Sinus Disorder, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pilonidal Sinus Disorder
- How many people
- 250 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2025to Dec 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients undergoing emergency surgery
- Previous pilonidal sinus surgery at the same site
- Inability to complete postoperative follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Etlik City Hospital
Ankara, Ankara, 06230
Muhammed Salih Süer, Attendant, +905445943494, suersalih@gmail.com
About this study
Official 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)
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
- Being tested
- No intervention (observational study)
- Keywords
- pilonidal sinus, risk factors, surgical wound dehiscence, Surgical Closure Technique
- Medical subject headings
- Pilonidal Sinus, Surgical Wound Dehiscence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention (observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 30 days after surgery
Secondary outcomes (1)
Time to Complete Wound Healing
Time from surgery to complete epithelialization of the surgical wound without discharge or need for additional intervention.
Measured: Up to 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start1 Dec 2025
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pilonidal Sinus DisorderStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Bahattin Bayar, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07370714
- Sponsor's protocol ID
- AEŞH-EK-2025-290
- Status last verified
- Jan 2026
- First submitted
- 23 Dec 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT07370714
- Acronym / sponsor ID
- AEŞH-EK-2025-290
- Conditions
- Pilonidal Sinus Disorder
- Keywords
- pilonidal sinus, risk factors, surgical wound dehiscence, Surgical Closure Technique
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pilonidal Sinus Surgery Patients | – | Other: No intervention (observational study)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Patients undergoing emergency surgery
- Previous pilonidal sinus surgery at the same site
- Inability to complete postoperative follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Pilonidal Sinus Surgery Patients |
Primary outcome
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.
1 secondary outcome
Time to Complete Wound Healing
Time frame: Up to 90 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pilonidal Sinus Disorder, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhammed Salih Süer, Attendant (+905445943494, suersalih@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Wound Dehiscence (time frame: Within 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.