Debridement and Laser Ablation Versus Debridement Alone in Pilonidal Disease

Medipol Health Group

Status: Completed

Conditions: Pilonidal Disease

Treatments: Device: Laser ablation

Study type: Observational

Funder types: Other

Identifiers

NCT05569135

E-10840098-772.02-2926

Details and patient eligibility

About

This study aims to investigate the effect of laser ablation (LA) in minimally invasive management of pilonidal disease (PD).

Data of the patients with PD who were eligible for simple debridement have been prospectively collected since March 2018, when laser ablation treatment came into use in our institution. Laser ablation treatment was offered to all eligible patients. All the patients underwent debridement (removal of hair and/or necrotic tissues through pits using a clamp/curette/brush) of PD; LA was added to the procedure in patients who were willing to have LA. The surgical outcome of two procedures was compared. The primary outcome measure was recurrence at 36 months.

Enrollment: 121 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with Class III, IV, and V pilonidal disease according to Tezel Navicular Area Classification
• Patients who underwent debridement for pilonidal disease

Exclusion criteria

• Patients with acute abscess (Tezel Class II)
• Antibiotic use within 4 weeks before surgery
• Patients lost to follow-up at 3,7 and 30 days; 6, 12 and 36 months

Trial design

121 participants in 2 patient groups

Debridement only

Description:

Debridement of the pilonidal cyst through pits was performed in this group. After the removal of hair and necrotic tissues through pits, the surgical site was covered with a simple gauze dressing for 1 day. Patients were allowed to return to work and sit freely on the day of surgery.

Debridiment with laser ablation

Description:

This group underwent the same procedure as the debridement group. After the removal of hair and necrotic tissues through pits, a diode laser at 1470 wavelength was inserted and the pilonidal cavity was ablated in a continuous fashion. The surgical site was covered with a simple gauze dressing for 1 day. Patients were allowed to return to work and sit freely on the day of surgery.

Treatment:

Device: Laser ablation