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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Punch excision | Experimental |
| |
| Traditional excision | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Excisional surgery of epidermal cyst | Procedure | Traditional extirpation of cyst en toto |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Cyst Recurrence | Recurrence of cyst after removal | 16 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suephy C Chen, MD | Emory University Department of Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlanta VA Medical Center | Decatur | Georgia | 30322 | United States |
Patients were excluded if the cysts were inflamed, infected, or ruptured based on characteristic physical examination findings.
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
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| ID | Title | Description |
|---|---|---|
| FG000 | Punch Excision | Punch incision of epidermal cyst : removal of cyst first with incisional effort with a punch biopsy tool |
| FG001 | Traditional Excision | Excisional surgery of epidermal cyst : Traditional extirpation of cyst en toto |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Punch Excision | Punch incision of epidermal cyst : removal of cyst first with incisional effort with a punch biopsy tool |
| BG001 | Traditional Excision | Excisional surgery of epidermal cyst : Traditional extirpation of cyst en toto |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Cyst Recurrence | Recurrence of cyst after removal | Posted | Number | participants | 16 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Punch Incision | Punch incision of epidermal cyst : removal of cyst first with incisional effort with a punch biopsy tool |
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The limitations of this study include the small, predominately male patient population, lack of complete follow-up of secondary endpoint measurements at every time point.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Suephy Chen | Emory University | 4047783084 | schen2@emory.edu |
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| ID | Term |
|---|---|
| D004814 | Epidermal Cyst |
| ID | Term |
|---|---|
| D003560 | Cysts |
| D009369 | Neoplasms |
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| Punch incision of epidermal cyst | Procedure | removal of cyst first with incisional effort with a punch biopsy tool |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Participants |
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Traditional Excision | Excisional surgery of epidermal cyst : Traditional extirpation of cyst en toto | 0 | 21 | 0 | 21 |
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