Skin Tags Clinical Trial
Official title:
Randomized Clinical Trial on Traditional Healing Versus Moist Healing Environment (MHE) Applied to Minor Surgery in the Exeresis of Skin Tags
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.
Study variables:
- Sex: Dichotomous qualitative variable: woman/man. Clinical history collection.
- Age: Discrete quantitative variable in years from the date of birth included in the
clinical history.
- Family history. Dichotomous qualitative variable: yes/no. According to the interview
with the participant, the family history of first and second degree skin tags will be
considered.
- Location of the lesion. Qualitative variable categorized in 6 items: Trunk/ armpit/
neck/ inguinal/ upper extremity/ lower extremity.
- Diabetes Dichotomous qualitative variable: yes/no. According to conditioning factors and
problems in the clinical history and interview with the participant. There are studies
that relate insulin resistance with the presence or not of skin tags 37, 38. To be able
to study if the results obtained are independent of the variable of suffering from DM.
- Cost: Continuous quantitative variable, expressed in euros. The cost will include the
performance of the technique in the first minor surgery visit, the post-surgical cures
and the follow-up visits. The standardized cost of each of the interventions has been
calculated according to the different techniques for approaching skin tag, from the
prices published in DOGC 6326 of 1 March 2013 Resolution SLT/353/2013 of 13 February on
the review of public price corresponding to the health services provided by the Institut
Català de la Salut. Apart from the price for the minor surgery visit of the different
approaches, the price of the follow-up visits has been calculated in case of prolonged
healing time of the lesion or the appearance of complications (infection or non-viable
tissue...).
- 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.
- Time invested by the professional: Discrete quantitative variable expressed in minutes.
The time invested in each visit will be recorded until it is healed.
- Complications:
Infection: Dichotomous qualitative variable: yes/no. Infection is considered when the wound
shows inflammation signs of infection.
- Devitalized tissue: Dichotomous qualitative variable: yes/no. The appearance of slough
will be observed.
- Technique: Qualitative variable categorized in 4 items:
- Dry Cure - Electrocoagulation.
- Dry Cure - Cryotherapy.
- Dry Cure - Silver Nitrate.
- Cure in a moist healing environment.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT06315946 -
Efficacy of a Cryogenic Medical Device on Skin Tags Versus a Comparator Product.
|
N/A |