Randomized Clinical Trial on Skin Tags Approachment.

NCT04161274 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 275

Last updated 2020-07-29

No results posted yet for this study

Summary

Skin tags are a benign dermal disease very frequent in the general population. Their exeresis is indicated in case of discomfort of the affected person (usually because of friction or increase in size). In the minor surgery guidelines, their extraction is recommended with cryotherapy, electrocoagulation or shaving with cauterization of silver nitrate (traditional healing techniques).

This randomized clinical trial proposes its extraction with a non before referenced technique in the manuals of minor surgery and that is nowadays applied with very good outcomes in the domain of pressure ulcers, chronic wounds and, in recent years, in acute wounds; the moist healing environment. Therefore, the investigators propose the surgical exeresis of the fibroid in the most proximal part of the pendulum with the subsequent placement of a thin hydrocolloid dressing.

The objective of this trial is to compare the traditional healing with the moist healing environment in minor surgery, analyzing costs, time invested by the professional, healing time and their respective complications.

Expected results: faster healing and lower cost are expected with the new technique. By contrast, more complications are expected in the techniques of cryotherapy and silver nitrate.

Applicability / Relevance: it is a common pathology usually treated in the minor surgery office or routine visit. Therefore, it can show us which treatment leads to fewer complications for the patient and which is more cost-efficient for the health system.

Conditions

  • Skin Tags

Interventions

PROCEDURE

Traditional method: Electrosurgery

The patient will be prepared before this technique by removing all metal objects in his possession. The area should be disinfected with a local antiseptic, leaving the area aseptic. Afterwards, perilesional infiltrated local anaesthesia (subcutaneous or intradermal) will be applied. Once the area has been anaesthetised, excision is made with scissors cutting through the most proximal part of the skin tag pendulum and the lesion is coagulated with the handle or knife of the electrocoagulator (previously regulated with the intensity in coagulation mode). The resulting abrasion will form an eschar that will be disinfected with povidone-iodine, and a protective dressing of sterile occlusive gauze bandage will be placed. Indications to the patient: the project participant will be instructed to dry the area with povidone-iodine antiseptic and not to expose the area to extreme humidity or sunlight.

PROCEDURE

Traditional method: Cryotherapy

The patient should be prepared: the area should be disinfected with a local antiseptic, leaving the area aseptic. for a few minutes the tip of an Adson forceps will be introduced in a container with liquid nitrogen until freezing. It will then be applied to the most proximal part of the skin tag pendulum until it is observed that the frostbite has reached the base of the lesion and the surface becomes whitish, with a halo of 1-3 mm. When this happens, it will be excise above the frost part in the pendulum. After application, it is disinfected with povidone- iodine and covered with a protective dressing of sterile occlusive gauze plaster. It will then form an eschar. Indications to the patient: the project participant will be instructed to dry the area with povidone-iodine antiseptic and not to expose the area to extreme humidity or sunlight.

PROCEDURE

Traditional method: Silver nitrate

The patient should be prepared: the area should be disinfected with a local antiseptic, leaving the area aseptic. Excision will be made with scissors of the skin tag cutting through the most proximal part of the skin tag pendulum, then cauterized with the tip of the silver nitrate rod, trying not to apply in the perilesional zone. The resulting abrasion will form an eschar that will be disinfected with povidone-iodine, and a protective dressing of sterile occlusive gauze bandage will be placed. Indications to the patient: the project participant will be instructed to dry the area with povidone-iodine antiseptic and not to expose the area to extreme humidity or solar rays.

PROCEDURE

Moist healing environment method

The patient should be prepared: the area should be disinfected with a local antiseptic, leaving the area aseptic. Excision will be made with scissors of the skin tag by cutting through the most proximal part of the pendulum of the skin tag, later it will be disinfected with chlorhexidine and thin hydrocolloid dressing will be placed. Indications to the patient: the project participant will be told not to touch the dressing until the next control after 3 days with the research team. In case of incidents with the dressing (fall of the dressing), the patient will be given a replacement dressing for this purpose and be able to restore it immediately. It is recommended not to expose the area to the solar rays

Sponsors & Collaborators

  • Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

    lead OTHER

Principal Investigators

  • Laura Paloma Fürstenheim Milerud · ICS

  • Gemma Amat i Camats · ICS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2020-06-01
Completion
2020-06-01

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 NCT04161274 on ClinicalTrials.gov