Randomized Clinical Trial on Skin Tags Approachment.

NCT04161274 | Completed

• 1 other identifier: IDIAP JordiGol
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

minor surgery procedures; wounds and injuries; moist healing environment; fibroma; nursing; skin diseases

Outcome Measures

Primary Outcomes (1)

• Healing time

  Discrete quantitative variable expressed in days. It will be considered 'healing' when the lesion has concluded the phases of inflammation and granulation/epithelialization. It will be the moment when it does not require any cure and lacks non-viable tissue (the days in the remodeling phase in which the participant uses skin care such as moisturizing, sun protection... will not be counted). For the monitoring of this variable, in the follow-up visits, the state of scarring will be evaluated and if it is already healed, it will be asked on what day prior to the visit, the lesion did not need any special cure and lacked non-viable tissue.

  through study completion, an average of 1 year

Study Arms (4)

Traditional method: Electrosurgery

ACTIVE COMPARATOR

Local anaesthesia and excision with a scalpel connected to the electric current, according to the voltage. Traditional cure with alcohol/Betadine. Photograph to the lesion before and after the intervention and in each follow-up visit. Follow-up visits every 3 days until the lesions cicatrization.

Procedure: Traditional method: Electrosurgery

Traditional method: Cryotherapy

ACTIVE COMPARATOR

Application of liquid nitrogen to cause freezing. Traditional cure with alcohol/Betadine. Photograph to the lesion before and after the intervention and in each follow-up visit. Follow-up visits every 3 days until the lesions cicatrization.

Procedure: Traditional method: Cryotherapy

Traditional method: Silver nitrate

ACTIVE COMPARATOR

Excision is made with the scissors and a rod is applied containing silver nitrate with caustic power on the wound. Traditional cure with alcohol/Betadine. Photograph to the lesion before and after the intervention and in each follow-up visit. Follow-up visits every 3 days until the lesions cicatrization.

Procedure: Traditional method: Silver nitrate

Moist healing environment

EXPERIMENTAL

Excision is made with the scissors, afterwards pressure, clorhexidine and a hydrocolloid dressing when the skin is dry. Photograph to the lesion before and after the intervention and in each follow-up visit. Follow-up visits every 3 days until the lesions cicatrization.

Procedure: Moist healing environment method

Interventions

Traditional method: Electrosurgery PROCEDURE

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.

Traditional method: Electrosurgery

Traditional method: Cryotherapy PROCEDURE

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.

Traditional method: Cryotherapy

Traditional method: Silver nitrate PROCEDURE

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.

Traditional method: Silver nitrate

Moist healing environment method PROCEDURE

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

Moist healing environment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Injuries that, by increasing in size or by rubbing with some element of clothing, cause discomfort for the user (pain, bleeding, ...).
• Only small skin tags (≤0,5x0,5cm) will be accepted for study.
• People who voluntarily agree to enter the clinical trial and sign the Informed Consent.

You may not qualify if:

• Immunosuppressed patients: people with immunosuppressive treatments, long-lasting corticoids, chemotherapy or radiotherapy, biological treatments and immunosuppressive diseases such as HIV infection, hematological diseases, transplants... (these people have a compromised immune response and are more susceptible to infections and their complications.
• Patients with anticoagulant treatment: oral anticoagulants antagonists of vitamin K (AVK: acenocoumarol, warfarin) or direct oral anticoagulants (DOACs: apixaban, dabigatran, rivaroxaban, edoxaban).
• According to location: those areas of greater risk of infection due to their location (genital areas) or those areas with aesthetic compromise.
• According to size: in order to ensure the homogeneity of the lesions, large lesions (larger than 0,5x0,5cm) will be discarded.
• Allergic to silver (according to medical history or patient reference).

Sponsors & Collaborators

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

Study Sites (1)

Abs Balaguer

Balaguer, Lleida, 25600, Spain

Location

MeSH Terms

Conditions

Wounds and Injuries; Fibroma; Skin Diseases

Condition Hierarchy (Ancestors)

Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Skin and Connective Tissue Diseases

Study Officials

• Laura Paloma Fürstenheim Milerud

  ICS

  PRINCIPAL INVESTIGATOR

• Gemma Amat i Camats

  ICS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: November 13, 2019
• Study Start: January 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: July 29, 2020

Record last verified: 2019-07

Locations

ES (1)