Epidermal Cyst
Conditions
Keywords
Epidermal cyst, Epidermoid cyst, Sebaceous cyst, Pilar cyst
Brief summary
The purpose of this trial is to compare two standard of care treatments for removing epidermal cysts. Surgical excision removes the entire cyst but requires a larger hole in the skin. A punch incision makes a smaller hole through which the cyst can be removed. The trial's purpose is to determine if one method is better than another in terms of recurrence, infection, or other side effects.
Detailed description
The purpose of this trial is to compare two standard of care treatments for removing epidermal cysts. Surgical excision removes the entire cyst but requires a larger hole in the skin. A punch incision makes a smaller hole through which the cyst can be removed. The trial's purpose is to determine if one method is better than another in terms of recurrence, infection, or other side effects. Patients with epidermal cysts will be randomized to having the cyst removed by surgical excision or by a smaller punch incision followed by removal of the cyst through the smaller hole. The skin will be stitched shut in both cases. A short survey about how the cyst affects the patient will be given before the cyst is removed. When the stitches are removed 2 weeks later, photographs will be taken and a survey regarding satisfaction with the procedure will be given. Two additional phone surveys, given at 4 and 12 months after the procedure, wil be given to ask about recurrence, satisfaction with the procedure, side effects, and how the cyst affected the patient's life. The study doctor will be blinded as to which procedure each subject underwent. Forty subjects will be recruited at the Atlanta Veteran's Administration Medical Center
Interventions
PROCEDUREExcisional surgery of epidermal cyst
Traditional extirpation of cyst en toto
PROCEDUREPunch incision of epidermal cyst
removal of cyst first with incisional effort with a punch biopsy tool
Sponsors
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult 18 years or older * Epidermal cyst 1-3 cm in diameter on the trunk
Exclusion criteria
* Infected cyst requiring systemic antibiotics * Pregnant females * Unable to return to clinic for suture removal * Previous excision of target cyst
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Cyst Recurrence | 16 months | Recurrence of cyst after removal |
Countries
United States
Participant flow
Recruitment details
subjects older than 18 years of age with 1-3 cm truncal EICs were selected via serial recruitment from the Atlanta Veterans Affairs Medical Center Dermatology clinic
Pre-assignment details
Patients were excluded if the cysts were inflamed, infected, or ruptured based on characteristic physical examination findings.
Participants by arm
| Arm | Count |
|---|---|
| Punch Excision Punch incision of epidermal cyst : removal of cyst first with incisional effort with a punch biopsy tool | 19 |
| Traditional Excision Excisional surgery of epidermal cyst : Traditional extirpation of cyst en toto | 21 |
| Total | 40 |
Baseline characteristics
| Characteristic | Traditional Excision | Punch Excision | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 5 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 14 Participants | 30 Participants |
| Age, Continuous | 59.0 years STANDARD_DEVIATION 9.9 | 60.3 years STANDARD_DEVIATION 11.8 | 59.6 years STANDARD_DEVIATION 10.7 |
| Region of Enrollment United States | 21 participants | 19 participants | 40 participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 19 Participants | 18 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 19 | 0 / 21 |
| serious Total, serious adverse events | 0 / 19 | 0 / 21 |
Outcome results
Primary
Number of Participants With Cyst Recurrence
Recurrence of cyst after removal
Time frame: 16 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Punch Incision | Number of Participants With Cyst Recurrence | 3 participants |
| Traditional Excision | Number of Participants With Cyst Recurrence | 2 participants |