Pilonidal SinusNCT06518499
Outcomes of Karydakis, Primary Closure, and Pit Picking Methods in the Treatment of Pilonidal Sinus: A Prospective Study in Women
An observational study of Pilonidal Sinus, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Although there are many methods for the surgical treatment of pilonidal sinus disease, the number of studies specific to women is limited in the literature. In addition to post-treatment recurrence and complication rates in women, aesthetic results are also of great importance. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pilonidal Sinus
- What is being tested?
- Pilonidal sinus surgery
- Type of treatment
- Surgery or procedure
- How many people
- 145 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2024to 20 Aug 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patients aged 18 and older with pilonidal sinus disease and three or fewer pits, with no previous surgical treatment.
Who may be able to join
- Female patients 18 years old and older
- Diagnosed with pilonidal sinus disease, having 3 or fewer pits.
- No previous surgical treatment for pilonidal sinus.
Who cannot join
- Under 18 years of age
- Pregnancy
- Presented with acute abscesses
- Patients with recurrent disease, Stage-R.
- >3 pit
- Collagen tissue disease
Show all 9Show fewer
- Exceed to navicular area
- Lateral extension in both directions
- Accidentally discovered (asymptomatic) sinus or with follow-up <12 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital
Istanbul, Other
Adnan Gundogdu
About this study
Although there are many methods for the surgical treatment of pilonidal sinus disease, the number of studies specific to women is limited in the literature. In addition to post-treatment recurrence and complication rates in women, aesthetic results are also of great importance. This study will compare the Karydakis procedure, a flap method, and the Bascom's pit-pick procedure, a minimally invasive procedure, in terms of recurrence, complications and aesthetics, especially in female patients with three or fewer pits.
Read the detailed description
This study is a single-center, prospective observational trial aimed at comparing the effectiveness of the Karydakis flap and Bascom's pit-pick methods in treating pilonidal sinus disease in women. Female patients aged 18 and over, with three or fewer pits, will be included, and each patient will be followed for 12 months. The Bascom pit-pick method will be performed under local anesthesia, while the Karydakis method will be performed under spinal or general anesthesia. Postoperative recovery time, complications, recurrence rates, and patient satisfaction will be evaluated. Ethics committee approval has been obtained (Approval No: TE 172, Date: June 12, 2024).
- Conditions
- Pilonidal Sinus
- Being tested
- Pilonidal sinus surgery
- Medical subject headings
- Pilonidal Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilonidal sinus surgeryProcedure or surgery
Bascom's Pit-Pick procedure, Primary Closure, Karydakis procedure
| Study group | Role | What they receive |
|---|---|---|
| Bascom's Pit-Pick procedure | The Bascom pit-pick procedure is performed under local anesthesia with the patient in a prone position, taking approximately 15-20 minutes. Pre-operative preparation includes shaving and cleaning the surgical area. Local anesthesia (lidocaine with adrenaline) is typically used, with general anesthesia as an alternative if needed. The surgical technique involves excising midline pits with a scalpel, removing infected granulation tissue and hairs through curettage or a lateral incision. Midline wounds and nearby secondary pits are sutured with polypropylene, while the lateral incision is left open and covered with a hydrofibre bandage to heal by secondary intention. Receives: Procedure: Pilonidal sinus surgery | |
| Primary Closure | The primary closure technique for pilonidal sinus involves placing the patient in a prone position under spinal or general anesthesia, shaving and cleaning the surgical area, and making an elliptical incision to remove the affected tissue. A skin flap is then mobilized from the surrounding area to cover the excision site, and the wound is closed with sutures. Receives: Procedure: Pilonidal sinus surgery | |
| Karydakis | The Karydakis primary closure procedure involves placing the patient in a prone position under spinal or general anesthesia. The surgical area around the natal cleft is shaved and cleaned thoroughly. A symmetric elliptical excision is performed 2 cm lateral to the midline, removing all affected pilonidal sinus tissue and some surrounding normal tissue. A skin flap, 2 cm wide and 1 cm thick, is mobilized from the contralateral side to cover the resultant defect. The flap is secured using a continuous suture technique, with the skin closed using polypropylene mattress sutures. A low-suction drain is used to standardize the procedure, removed when drainage decreases to less than 20 ml/day. Receives: Procedure: Pilonidal sinus surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence Rate
This measure evaluates the rate of pilonidal sinus disease recurrence in female patients undergoing Karydakis flap or Bascom's pit-pick surgical procedures over a 12-month period. Recurrence is defined as the reappearance of disease symptoms after the wound has completely healed.
Measured: 12 months post-surgery
Secondary outcomes (4)
Complication Rate
This measure records the incidence of postoperative complications such as infections (superficial or deep), seromas, hematomas, wound dehiscence (partial or complete), and anesthesia-related complications within the first 30 days post-surgery.
Measured: 30 days post-surgery
Aesthetic Outcome (Visual Analog Score for pain)
Assessment of aesthetic outcomes using the Visual Analog Scale (VAS) for pain. The VAS is a scale from 0 to 10, where 0 represents no pain and 10 represents the worst possible pain. Higher scores indicate worse outcomes.
Measured: Up to 1 year post-surgery
Healing Time
This measure records the time required for complete wound healing post-surgery, defined as the integrity along the incision line without any complications.
Measured: Up to 12 weeks post-surgery
Functional Recovery
This measure assesses the time taken for patients to resume daily activities comfortably.
Measured: Up to 24 weeks post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start1 Jul 2024
- Primary completion1 Jul 2026 (estimated)
- Study completion20 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pilonidal SinusStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 145 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06518499
- Sponsor's protocol ID
- Ivstrh 172
- Status last verified
- Jul 2024
- First submitted
- 12 Jul 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Karydakis, Primary Closure, and Pit Picking Methods in the Treatment of Pilonidal Sinus: A Prospective Study in Women
- ClinicalTrials.gov ID
- NCT06518499
- Acronym / sponsor ID
- Ivstrh 172
- Conditions
- Pilonidal Sinus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 20 Aug 2026 (estimated)
- First posted
- 24 Jul 2024 (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.
Although there are many methods for the surgical treatment of pilonidal sinus disease, the number of studies specific to women is limited in the literature. In addition to post-treatment recurrence and complication rates in women, aesthetic results are also of great importance. This study will compare the Karydakis procedure, a flap method, and the Bascom's pit-pick procedure, a minimally invasive procedure, in terms of recurrence, complications and aesthetics, especially in female patients with three or fewer pits.
Detailed description
This study is a single-center, prospective observational trial aimed at comparing the effectiveness of the Karydakis flap and Bascom's pit-pick methods in treating pilonidal sinus disease in women. Female patients aged 18 and over, with three or fewer pits, will be included, and each patient will be followed for 12 months. The Bascom pit-pick method will be performed under local anesthesia, while the Karydakis method will be performed under spinal or general anesthesia. Postoperative recovery time, complications, recurrence rates, and patient satisfaction will be evaluated. Ethics committee approval has been obtained (Approval No: TE 172, Date: June 12, 2024).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bascom's Pit-Pick procedure | – | Procedure: Pilonidal sinus surgeryThe Bascom pit-pick procedure is performed under local anesthesia with the patient in a prone position, taking approximately 15-20 minutes. Pre-operative preparation includes shaving and cleaning the surgical area. Local anesthesia (lidocaine with adrenaline) is typically used, with general anesthesia as an alternative if needed. The surgical technique involves excising midline pits with a scalpel, removing infected granulation tissue and hairs through curettage or a lateral incision. Midline wounds and nearby secondary pits are sutured with polypropylene, while the lateral incision is left open and covered with a hydrofibre bandage to heal by secondary intention. |
| Primary Closure | – | Procedure: Pilonidal sinus surgeryThe primary closure technique for pilonidal sinus involves placing the patient in a prone position under spinal or general anesthesia, shaving and cleaning the surgical area, and making an elliptical incision to remove the affected tissue. A skin flap is then mobilized from the surrounding area to cover the excision site, and the wound is closed with sutures. |
| Karydakis | – | Procedure: Pilonidal sinus surgeryThe Karydakis primary closure procedure involves placing the patient in a prone position under spinal or general anesthesia. The surgical area around the natal cleft is shaved and cleaned thoroughly. A symmetric elliptical excision is performed 2 cm lateral to the midline, removing all affected pilonidal sinus tissue and some surrounding normal tissue. A skin flap, 2 cm wide and 1 cm thick, is mobilized from the contralateral side to cover the resultant defect. The flap is secured using a continuous suture technique, with the skin closed using polypropylene mattress sutures. A low-suction drain is used to standardize the procedure, removed when drainage decreases to less than 20 ml/day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients aged 18 and older with pilonidal sinus disease and three or fewer pits, with no previous surgical treatment.
Key inclusion criteria (3 listed)
- Female patients 18 years old and older
- Diagnosed with pilonidal sinus disease, having 3 or fewer pits.
- No previous surgical treatment for pilonidal sinus.
Key exclusion criteria (9 listed)
- Under 18 years of age
- Pregnancy
- Presented with acute abscesses
- Patients with recurrent disease, Stage-R.
- >3 pit
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 |
|---|---|---|
| Pilonidal sinus surgeryBascom's Pit-Pick procedure, Primary Closure, Karydakis procedure | Procedure or surgery | Bascom's Pit-Pick procedure, Karydakis, Primary Closure |
Primary outcome
Recurrence Rate
Time frame: 12 months post-surgery
This measure evaluates the rate of pilonidal sinus disease recurrence in female patients undergoing Karydakis flap or Bascom's pit-pick surgical procedures over a 12-month period. Recurrence is defined as the reappearance of disease symptoms after the wound has completely healed.
4 secondary outcomes
Complication Rate
Time frame: 30 days post-surgery
Aesthetic Outcome (Visual Analog Score for pain)
Time frame: Up to 1 year post-surgery
Healing Time
Time frame: Up to 12 weeks post-surgery
Functional Recovery
Time frame: Up to 24 weeks post-surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Individual participant dataSharing planned: Yes
Related trials for Pilonidal Sinus
Recruiting
VAAPS Combined With Loose Seton Drainage for Postoperative Self-Care: A Prospective Single-Arm Cohort Study
Pilonidal Sinus Disease
Not yet recruiting
Teach-Back Discharge Education After Pilonidal Sinus Surgery
Pilonidal Sinus Disease, Pilonidal Sinus Treatment
Recruiting
ENVELOP: Wound Care Following Pilonidal Sinus Surgery
Pilonidal Sinus, Wound Healing
Not yet recruiting
Laser Coagulation of Pilonidal Sinus With/Without Intraoperative Ultrasound Control
Pilonidal Cyst Without Abscess
Not yet recruitingObservational study
Urinary Bladder Matrix (UBM) Registry
Tissue Repair, Soft Tissue Reconstruction
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. This study is not recruiting at the moment.
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, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research 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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 8 Oct 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adnan Gundogdu (+905367173909, adnangundogdu89@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence Rate (time frame: 12 months post-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 8 Oct 2024.