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

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.

Study Overview

• Status: Recruiting
• Conditions: Pilonidal Sinus

Detailed Description

Pilonidal sinus disease (PSD) is common, affecting approximately 26 in 100,000 people. Treatment options and outcomes vary significantly. Chronic symptomatic pilonidal sinus disease primarily affects young adults and leads to substantial work loss. Due to the heterogeneous nature of clinical presentations, finding a single treatment approach for PSD has proven difficult. Future clinical studies might benefit from focusing on the best management strategies rather than the best technique.

Literature indicates that the minimally invasive pit-picking procedure has a general treatment success rate of 68%, with low postoperative complication rates, chronic pain, and high patient satisfaction regarding cosmetic appearance. It is seen as a better option in terms of pain, wound healing time, and complication rates. For simple, uncomplicated pilonidal sinus cases, the pit-picking method is an alternative to flap surgery in terms of wound healing and recurrence.

Particularly for patients with fewer than two pits and no lateral extensions, crystallized phenol application (CPT) is a good alternative to modified Limberg flap surgery and other surgical procedures. CPT, being a minimally invasive procedure performed under local anesthesia, has higher success rates after recurrent applications and shorter hospital stays. Long-term results for CPT treatment are also quite successful. Studies show that in addition to endoscopic pilonidal sinus treatment, crystallized phenol treatment is safe, well-tolerated, and provides quick and lasting recovery without recurrence over the follow-up period.

The presented study aims to compare the effectiveness of three different treatment methods for pilonidal sinus disease: Pit Picking, CPT Application, and Combined Pit Picking and CPT Application. The study will evaluate the short- and long-term results, treatment success, incidence of postoperative complications, chronic pain levels, recurrence rates, and patient satisfaction. Additionally, the study will examine the effects of these methods on hospital stay, wound healing time, and workforce loss. The presented study aims to determine whether minimally invasive procedures and CPT treatment offer better management strategies for pilonidal sinus disease. The findings are expected to contribute to identifying the most suitable treatment method for pilonidal sinus disease.

• Study Type: Observational
• Enrollment (Estimated): 165

Contacts and Locations

• Study Contact: Name: Adnan Gundogdu; Phone Number: +905367173909; Email: adnangundogdu89@gmail.com

Study Locations

• Turkey
  • Other
    • İstanbul, Other, Turkey, 34785
      • Recruiting
      • Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital
      • Contact: Adnan Gundogdu; Phone Number: +905367173909; Email: adnangundogdu89@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• Having two pits or less

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence Rate	Evaluation of the rate of disease recurrence after treatment.	Up to 12 months post-treatment
Chronic Pain Level	Assessment of chronic pain levels in patients following treatment using the Visual Analog Scale (VAS). 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.	Up to 3 months post-treatment
Patient Satisfaction	Measurement of patient satisfaction with the treatment process and outcomes using the Patient and Observer Scar Assessment Scale (POSAS). POSAS is a scale from 1 to 10, where 1 represents the best outcome and 10 represents the worst outcome. Higher scores indicate worse outcomes.	Up to 12 months post-treatment

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: July 17, 2024
• First Submitted That Met QC Criteria: July 22, 2024
• First Posted (Actual): July 24, 2024

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: October 5, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Pilonidal sinus
• Additional Relevant MeSH Terms: Neoplasms; Cysts; Pilonidal Sinus
• Other Study ID Numbers: Ivstrh 214

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No