Study to Evaluate the Efficacy of Removing Skin Tags With Digiclamp

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to assess the efficacy of using the Digiclamp device to remove achrocordons (skin tags). The hypothesis is that utilizing the device will result in low rates of re-occurrence, scars, scar tissue and discoloration at the site of removal.

Detailed Description
-----------------
Achrocorodons, or skin tags, are superficial cutaneous lesions that occur most commonly among middle aged adults, obese persons and those who suffer from Type 2 Diabetes. In most cases, the tags are not bothersome but there are instances when they can become infected or irritated. There are several skin tag removal options available, including suture ligature, freezing, cautery or excision. These procedures are often done in a dermatology office and are an out-of-pocket cost. The Digiclamp device was invented to make skin tag removal procedures more accessible. The Digiclamp represents a new option that when placed in the hands of primary care clinicians, it will allow them to remove skin tags without having to purchase expensive devices or to refer them to a Dermatologist. The device is disposable, and relatively painless when used correctly, and requires minimal training. The investigator is planning to enroll 100 subjects, who will have skin tags removed using the Digiclamp device. Subjects will return for follow up at 2-3 months after skin tag removal.

Official Title
-----------------
Research on Current Prototypes of the Digiclamp. Short Term and Long Term Outcomes of Treating Adults With Achrocordons (Skin Tags)

Conditions
-----------------
Achrochordon

Intervention / Treatment
-----------------
* Device: Digiclamp (Skin tag removal initial plus follow-up)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with simple skin tag(s) measuring up to 1 centimeter width at the base of the skin tag Exclusion Criteria: Subjects with skin tags measuring greater than 1 centimeter width at the base Subjects whose skin tags appear infected or may need to be evaluated by pathology Subjects whose skin tags are located in genital areas or eyelids Pregnant subjects Subjects with bleeding disorders.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Skin tag removal initial visit plus follow-up<br>Removal of skin tags 1 cm or less using Digiclamp and follow-up 2-3 months after skin tag removal to assess functionality and effectiveness of the device. | Device: Digiclamp (Skin tag removal initial plus follow-up)<br>* Skin tag will be assessed for size, location, and overall appearance. After assessment and confirmation that the skin tag is not infected or possibly malignant, the site will be photographed, prepped with an antimicrobial solution, anesthetized, and removed using the Digiclamp. A bandaid will be applied to the site. Site of skin tag removal will be photographed to document lesion recurrence and presence of scar tissue or hyperpigmentation. Subjects will be asked to complete a brief survey about their satisfaction with the use of Digiclamp.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Re-occurrence Rate of Skin Tags | Percentage of subjects who experience a re-occurrence of the skin tag at the removal site. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Permanent Scars Among Lesion Sites | Percentage of subjects who develop a scar at the removal site | 3 months | 
| Percentage of Scar Tissue Formation Among Lesion Sites | Percentage of subjects who develop scar tissue or keloid at the site of removal | 3 months | 
| Percentage of Discoloration Among Subjects | Percentage of subjects who develop discoloration at the site of removal | 3 months | 
| Percentage of Pain/Numbness Where Skin Tag Was Removed | Percentage of subjects who develop pain/numbness at the site of removal | 3 months | 
| Satisfaction With Pain Post Procedure | All study participants were asked three questions in a post procedure satisfaction survey. 1. How satisfied are you with the amount of pain you experienced while having your skin tag removed? Study participants responded whether they were very satisfied, somewhat satisfied, neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied. Subjects were counted in each category and reported. | 2 months post procedure | 
| Satisfaction With What the Area Looked Like Post Procedure | All study participants were given a satisfaction survey 2 months post procedure. Subjects had to choose if they were very satisfied:, somewhat satisfied, neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied with how the area looks where the skin tag used to be. Subjects in each category were counted and reported. | 2 months post procedure | 
| How Likely to Recommend the Procedure to Friends and Family | All study participants were asked a satisfaction survey post procedure and whether they would recommend the procedure to friends and family. Categories for response were: very likely, somewhat likely, neither likely nor unlikely, somewhat unlikely, very unlikely. Subjects in each category were counted and reported. | 2 months post procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
skin tag