An interventional study of Karydakis Flap Procedure and Burow's Triangle Advancement Flap Procedure in Pilonidal Sinus and Sacrococcygeal Pilonidal Disease, sponsored by Istanbul Sultanbeyli State Hospital. Recruiting at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-09-28.
Sponsored by Istanbul Sultanbeyli State Hospital · Not applicable, Interventional, and Treatment
In this study, we aim to compare the Karydakis flap and Burow's Triangle Advancement Flap techniques applied in the surgical treatment of pilonidal sinus in terms of complications, time to return to normal activity, and recurrence.
Pilonidal sinus disease (PSD) is a chronic and inflammatory disease that is often generated in the sacrococcygeal region. It is commonly observed in puberty and young adult period and usually affects men. The incidence of pilonidal sinus disease is 26:100,000 and rising globally.
PSD risk factors contain young age, obesity, male gender, Mediterranean ethnicity, deep natal cleft, hairiness, and poor hygiene. It has been shown that PSD incidence increases in parallel with body weight. The precise etiology of pilonidal sinus disease is unclear. Many conservative and surgical methods have been described in treating pilonidal sinus disease. After the sinus area is excised, excision with laying open (secondary healing), excision with primary closure, marsupialization, and various flap techniques can be applied in surgical treatment. The primary principle in treatment is to ensure that the patient returns to normal life as soon as possible and eliminate recurrences. Although the best surgical technique in treating pilonidal sinus is controversial, the ideal operation should be cost-effective, simple to perform, short hospital stay, and have a low recurrence and complication rates. There is no definite consensus on an ideal technique yet.
In this study, we aim to compare the Karydakis flap and Burow's Triangle Advancement Flap techniques applied in the surgical treatment of pilonidal sinus in our clinic in terms of complications (wound dehiscence, seroma, hematoma, surgical site infection), time to return to normal activity, and recurrence.
109 studies on the registry are indexed under Pilonidal Sinus; 32 are open to participants now.
This study's planned enrollment of 80 is close to the median of 80 across 72 interventional studies indexed under Pilonidal Sinus.
Browse Pilonidal Sinus studies →Istanbul Sultanbeyli State Hospital is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Vertical eccentric elliptical incision down to the post-sacral fascia, complete removal of unhealthy tissue, and normal tissue around the cyst and sinus tracts. Mobilization of the medial wound edge and advancement of the skin. Flap along the midline to the post-sacral fascia and suturing its margin to the lateral wound margin.
Procedure: Karydakis Flap Procedure
The flap is incised along the base of the wedge-shaped defect, and a small Burow's triangle is excised on the opposite side. The skin is mobilized and shifted in the direction of the arrow to close the defect. Excising the small Burow's triangle eliminates a dog ear at the base of the flap.
Procedure: Burow's Triangle Advancement Flap Procedure
Pilonidal sinus surgery will be performed with the Karydakis Flap procedure.
Pilonidal sinus surgery will be performed with the Burow's Triangle Advancement Flap procedure.
Pain score according to the visual analogue scale
Postoperative pain after surgery ( measured by the visual analog score with 1 being minimum score and 10 being maximum score)
Time frame: 1-3 days
Postoperative wound healing time
Number of weeks of complete duration epithelialization of the wound
Time frame: 4 to 6 weeks
Procedure-related complications
Number of complications; related to the surgery, Type (wound dehiscence, seroma, hematoma, surgical site infection)
Time frame: 1 to 6 weeks
Time to return to normal activity
The number of weeks it passes the patient to return to normal activity.
Time frame: 4 to 6 weeks
Recurrence of Pilonidal Sinus
Number of patients with recurrence pilonidal disease
Time frame: 6 - 12 months
Plan to share: No
Started Jun 2022 (actual). Primary completion is estimated for Jun 2024, 23 months after the start.
Of 35 interventional studies with no phase under Pilonidal Sinus, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 35. This study's planned 23 months is close to that.
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Istanbul Sultanbeyli State Hospital