Comparison of Two Different Flap Methods in the Treatment of Pilonidal Sinus Disease

Atlas University

Status: Completed

Conditions: Pilonidal Sinus

Treatments: Procedure: Surgical treatment of pilonidal sinus disease

Study type: Interventional

Funder types: Other

Identifiers

NCT05851690

E-16-975

Details and patient eligibility

About

Sacrococcygeal pilonidal sinus disease (PSD) has been defined as a disease characterized by chronic inflammation and recurrent infections caused by the movement of hair toward the gluteal sulcus. This condition is especially seen in young men and negatively affects the quality of life of patients and prevents them from performing their work and school activities. The treatment options for PSD range from the use of antibiotics alone to reconstructed excision with tissue flaps. Although the optimal surgical treatment option remains controversial, expectations from the ideal surgical treatment include low recurrence and postoperative complication rates, early wound healing, short hospital stay, early return to work, and good cosmetic outcomes. The aim of this study was to compare the efficacy of the different flap techniques in the surgical treatment of PSD and evaluate the long-term outcomes of patients.

Enrollment: 102 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Underwent surgery due to pilonidal sinus disease

Exclusion criteria

• Patients with a history of previous pilonidal sinus surgery,
• An acute pilonidal abscess,
• immunodeficiency,
• using immunosuppressive drugs,
• refuse to participate in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

Bilateral Parallel Elliptic Flap

Active Comparator group

Description:

Patients operated with the bilateral parallel elliptic flap technique.

Treatment:

Procedure: Surgical treatment of pilonidal sinus disease

Karydakis Flap

Active Comparator group

Description:

Patients operated with the karydakis flap technique.

Treatment:

Procedure: Surgical treatment of pilonidal sinus disease