An interventional study of Digiclamp (Skin tag removal initial plus follow-up) in Achrochordon, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-15.
Sponsored by University of Florida · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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)
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.
Re-occurrence Rate of Skin Tags
Percentage of subjects who experience a re-occurrence of the skin tag at the removal site.
Time frame: 3 months
Percentage of Permanent Scars Among Lesion Sites
Percentage of subjects who develop a scar at the removal site
Time frame: 3 months
Percentage of Scar Tissue Formation Among Lesion Sites
Percentage of subjects who develop scar tissue or keloid at the site of removal
Time frame: 3 months
Percentage of Discoloration Among Subjects
Percentage of subjects who develop discoloration at the site of removal
Time frame: 3 months
Percentage of Pain/Numbness Where Skin Tag Was Removed
Percentage of subjects who develop pain/numbness at the site of removal
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 2 months post procedure
| Milestone | Skin Tag Removal Initial Visit Plus Follow-up |
|---|---|
| Started | 20 |
| Completed | 20 |
| Not completed | 0 |
Percentage of subjects who experience a re-occurrence of the skin tag at the removal site.
| Participants | Skin Tag Removal Initial Visit Plus Follow-up |
|---|---|
| Re-occurrence Rate of Skin Tags | 0 |
Percentage of subjects who develop a scar at the removal site
| Participants | Skin Tag Removal Initial Visit Plus Follow-up |
|---|---|
| Percentage of Permanent Scars Among Lesion Sites | 1 |
Percentage of subjects who develop scar tissue or keloid at the site of removal
| Participants | Skin Tag Removal Initial Visit Plus Follow-up |
|---|---|
| Percentage of Scar Tissue Formation Among Lesion Sites | 0 |
Percentage of subjects who develop discoloration at the site of removal
| Participants | Skin Tag Removal Initial Visit Plus Follow-up |
|---|---|
| Percentage of Discoloration Among Subjects | 3 |
Percentage of subjects who develop pain/numbness at the site of removal
| Participants | Skin Tag Removal Initial Visit Plus Follow-up |
|---|---|
| Percentage of Pain/Numbness Where Skin Tag Was Removed | 0 |
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.
| Participants | Skin Tag Removal Initial Visit Plus Follow-up |
|---|---|
| Very satisfied | 20 |
| Somewhat satisfied | 0 |
| Neither satisfied nor dissatisfied | 0 |
| Somewhat dissatisfied | 0 |
| Very dissatisfied | 0 |
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.
| Participants | Skin Tag Removal Initial Visit Plus Follow-up |
|---|---|
| Very satisfied with how the area looked like where the skin tag used to be | 19 |
| Somewhat satisfied with what the area looked like | 1 |
| Neither satisfied nor dissatisfied | 0 |
| Somewhat dissatisfied | 0 |
| Very dissatisfied | 0 |
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.
| Participants | Skin Tag Removal Initial Visit Plus Follow-up |
|---|---|
| Very likely to recommend the procedure to friends and family | 20 |
| Somewhat likely | 0 |
| Neither likely nor unlikely | 0 |
| Somewhat unlikely | 0 |
| Very unlikely | 0 |
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Skin Tag Removal Initial Visit Plus Follow-up | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Continuous(years) | Skin Tag Removal Initial Visit Plus Follow-up |
|---|---|
| Mean | 45.8 ± 9.96 |
| Sex: Female, Male(Participants) | Skin Tag Removal Initial Visit Plus Follow-up |
|---|---|
| Female | 16 |
| Male | 4 |
| Race (NIH/OMB)(Participants) | Skin Tag Removal Initial Visit Plus Follow-up |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 20 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Weight(pounds) | Skin Tag Removal Initial Visit Plus Follow-up |
|---|---|
| Mean | 182 ± 43.9 |
| Height(inches) | Skin Tag Removal Initial Visit Plus Follow-up |
|---|---|
| Mean | 66.4 ± 3.07 |
| Number of lesions(lesions) | Skin Tag Removal Initial Visit Plus Follow-up |
|---|---|
| Mean | 2.5 ± 1.15 |
| Location of lesions(lesions) | Skin Tag Removal Initial Visit Plus Follow-up |
|---|---|
| neck | 19 |
| maxilla | 1 |
| axilla | 7 |
| back | 8 |
| areola | 1 |
| thigh | 2 |
| rib cage | 1 |
| buttock | 1 |
| mandible | 2 |
| shoulder | 2 |
| abdomen | 2 |
| chest | 4 |
| width of lesion(cm) | Skin Tag Removal Initial Visit Plus Follow-up |
|---|---|
| Mean | 0.404 ± 0.276 |
1 further baseline measures are reported on the registry.
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University of Florida