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LASER VERSUS CRYSTALLIZED PHENOL IN PILONIDAL SINUS DISEASE (PSD-L-F)

8. juli 2026 opdateret af: Vedat Kaplan, Sanliurfa Education and Research Hospital

A PROSPECTIVE RANDOMIZED COMPARISON OF LASER ABLATION AND CRYSTALLIZED PHENOL APPLICATION IN PRIMARY UNCOMPLICATED SACROCOCCYGEAL PILONIDAL SINUS DISEASE

This single-center prospective randomized parallel-group trial compares laser ablation and crystallized phenol application in adults with primary uncomplicated sacrococcygeal pilonidal sinus disease. The primary objective is to compare postoperative day 1 pain intensity between the two treatment methods. Secondary objectives include complete epithelialization by day 30, time to complete epithelialization, postoperative day 7 pain, duration of analgesic use, time to return to daily activities and work, early local complications, and 6-month recurrence.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a single-center, prospective, 1:1 parallel-group randomized clinical trial in adults with primary uncomplicated chronic sacrococcygeal pilonidal sinus disease. A total of 120 participants are planned, with 60 assigned to laser ablation and 60 assigned to crystallized phenol treatment. Randomization will be performed using computer-generated variable blocks, with stratification by pit number and Guner stage when feasible. Allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes. In both groups, a small incision of approximately 1 cm will be made, hair and debris within the sinus cavity will be removed, and curettage will be performed. After these shared preparation steps, the intervention group will receive Leonardo Mini 1470 nm diode laser treatment and the comparison group will receive crystallized phenol application. Repeat sessions with the same assigned treatment may be performed when needed within the secondary healing protocol. The primary endpoint is postoperative day 1 pain intensity measured by Visual Analog Scale. The main secondary endpoint is complete epithelialization at day 30. Other secondary outcomes include time to complete epithelialization, postoperative day 7 pain, duration of analgesic use, time to return to daily activities and work, early local complications, and recurrence at 6 months.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

120

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Age 18 years or older
  • Diagnosis of primary chronic sacrococcygeal pilonidal sinus disease
  • Uncomplicated disease
  • Suitability for minimally invasive treatment
  • Provision of written informed consent

Exclusion Criteria:

  • Acute pilonidal abscess
  • History of pilonidal abscess drainage
  • Previous surgical or interventional treatment for pilonidal sinus disease
  • Recurrent pilonidal disease
  • Complex pilonidal disease or marked lateral extension
  • Immunosuppression, chronic steroid use, or systemic conditions that may significantly impair wound healing
  • Inability to attend regular follow-up
  • Refusal to participate in the study

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Laser ablation
Participants undergo shared sinus preparation followed by laser ablation using a Leonardo Mini 1470 nm diode laser.
Procedure: Laser Ablation
After a small incision, hair and debris removal, and curettage, laser ablation is performed using a Leonardo Mini 1470 nm diode laser.
Aktiv komparator: Crystallized phenol
Participants undergo shared sinus preparation followed by crystallized phenol application to the sinus cavity.
Procedure: Crystallized phenol application
After a small incision, hair and debris removal, and curettage, crystallized phenol is applied to the sinus cavity.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postoperative day 1 pain score
Tidsramme: Postoperative day 1
Pain intensity on postoperative day 1 assessed using a 0 to 10 Visual Analog Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain; higher scores indicate worse pain.
Postoperative day 1

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Complete epithelialization at day 30
Tidsramme: Postoperative day 30
Presence or absence of complete epithelialization of the wound at postoperative day 30.
Postoperative day 30
Time to complete epithelialization
Tidsramme: Up to 30 days
Time from treatment to complete epithelialization, measured in days.
Up to 30 days
Postoperative day 7 pain score
Tidsramme: Postoperative day 7
Pain intensity on postoperative day 7 assessed using a 0 to 10 Visual Analog Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain; higher scores indicate worse pain.
Postoperative day 7
Duration of analgesic use
Tidsramme: Up to 30 days
Duration of postoperative analgesic use, measured in days.
Up to 30 days
Time to return to daily activities
Tidsramme: Up to 30 days
Time required to return to normal daily activities, measured in days.
Up to 30 days
Time to return to work
Tidsramme: Up to 30 days
Time required to return to work, measured in days.
Up to 30 days
Incidence of early local complications
Tidsramme: Within 30 days after treatment
Number and proportion of participants who develop any early local postoperative complication.
Within 30 days after treatment
Recurrence at 6 months
Tidsramme: 6 months
Presence or absence of recurrent pilonidal sinus disease by 6 months after treatment.
6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sanliurfa Education and Research Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. juli 2026

Primær færdiggørelse (Anslået)

1. marts 2027

Studieafslutning (Anslået)

1. marts 2027

Datoer for studieregistrering

Først indsendt

8. juli 2026

Først indsendt, der opfyldte QC-kriterier

8. juli 2026

Først opslået (Faktiske)

14. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SEAH-PİSİ

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data will not be shared because this is a single-center clinical study involving sensitive patient-level data, and there is no pre-specified institutional mechanism for external data sharing. Only aggregated, de-identified study results will be reported.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Sacrococcygeal Pilonidal sinus sygdom

Kliniske forsøg med Laser Ablation

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Betingelser

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