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Clinical Trial to Test the Phenolization in Sacrococcygeal Pilonidal Disease

NCT05404243 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2022-06-07

No results posted yet for this study

Summary

Randomized clinical trial to test the efficacy and safety of phenolization in uncomplicated Sacrococcygeal pilonidal disease

Conditions

  • Sacrococcygeal Fistula
  • Pilonidal Sinus
  • Pilonidal Disease
  • Pilonidal Disease of Natal Cleft

Interventions

DRUG

phenolization

In case of phenolization group, an Abbocath catheter 18 G is introduced into the cystic cavity. Undiluted 88% phenol is instilled into the cavity, ensuring that the cystic cavity is filled. It is maintained for 5 min until complete coagulation of the cyst is achieved.

PROCEDURE

Conventional surgery

In case of conventional surgery, entire exeresis is performed by means of an electric scalpel

Sponsors & Collaborators

  • HJ23

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2021-12-01
Completion
2022-05-01

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05404243 on ClinicalTrials.gov