Comparison of Pit Picking, Phenol and Combined Pit Picking and Phenol Applications in Pilonidal Sinus Treatment

NCT06517472 | Recruiting

• 1 other identifier: Ivstrh 214
• Study Type: observational
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

Pilonidal sinus disease is a common condition, and treatment options and outcomes vary greatly. Chronic symptomatic pilonidal sinus disease (PSD) primarily affects young adults and causes work loss. In this study, three treatment methods will be performed: the minimally invasive pit-picking procedure, crystallized phenol application (CPT), and a combined method (minimally invasive pit-picking procedure and CPT). The aim of this study is to compare the effectiveness of these three methods, evaluate short- and long-term results, and determine treatment success, the incidence of postoperative complications, chronic pain levels, recurrence rates, and patient satisfaction. Additionally, the effects of these methods on hospital stay, wound healing time, and workforce loss will also be examined.

Conditions

Pilonidal Sinus

Keywords

Pilonidal sinus

Outcome Measures

Primary Outcomes (2)

• Treatment Success

  The primary outcome measure will evaluate the effectiveness of three different treatment methods for pilonidal sinus disease: Pit Picking, Crystallized Phenol (CPT) Application, and Combined Pit Picking and CPT Application. Effectiveness will be determined by the absence of disease recurrence and complete healing.

  Up to 12 months post-treatment

• Postoperative Complications

  This measure will assess the incidence of postoperative complications such as infection and pain.

  Up to 3 months post-treatment.

Secondary Outcomes (3)

• Recurrence Rate

  Up to 12 months post-treatment

• Chronic Pain Level

  Up to 3 months post-treatment

• Patient Satisfaction

  Up to 12 months post-treatment

Study Arms (3)

Bascom's pit-picking

In the pit-picking technique, midline pits will be excised with minimal tissue removal (skin margin \<1 mm). Hairs in the sinuses will be removed along with the curetted tissues. The midline excision areas and secondary pits excised near the midline will be closed with 3-0 polypropylene.

Crystallized phenol

In crystallized phenol treatment, the pit will be expanded with the help of a clamp, and after confirming it is uncomplicated, hair and infected tissue will be cleaned. Nitrofurazone will be applied to the pit edges. Crystallized phenol will be filled into the sinus with the help of a clamp.

Combined treatment

In the combined treatment, crystallized phenol will be applied after pit picking, and the pit area will be left to secondary healing.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Female patients aged 18 and older with pilonidal sinus disease and two or fewer pits, with no previous surgical treatment.

You may qualify if:

• Having two pits or less

You may not qualify if:

• With bilateral lateral extension,
• Stage-R with recurrent disease
• Number of pits more than three pits,
• Collagen tissue disease,
• Patients with a postoperative follow-up period of less than 12 months

Sponsors & Collaborators

• Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital: lead

Study Sites (1)

Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital

Istanbul, Other, 34785, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pilonidal Sinus

Condition Hierarchy (Ancestors)

Cysts; Neoplasms

Central Study Contacts

Adnan Gundogdu

CONTACT

+905367173909; adnangundogdu89@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 24, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: October 8, 2024

Record last verified: 2024-07

Locations

TU (1)