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Comparison of Excision Versus Punch Incision in the Treatment of Epidermal Cysts


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Epidermal Cyst

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Trial Information

Comparison of Excision Versus Punch Incision in the Treatment of Epidermal Cysts


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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Recurrence of epidermal cyst

Outcome Time Frame:

16 months

Safety Issue:

No

Principal Investigator

Suephy C Chen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University Department of Dermatology

Authority:

United States: Food and Drug Administration

Study ID:

1023-2004

NCT ID:

NCT00165958

Start Date:

January 2005

Completion Date:

July 2012

Related Keywords:

  • Epidermal Cyst
  • Epidermal cyst
  • Epidermoid cyst
  • Sebaceous cyst
  • Pilar cyst
  • Cysts
  • Epidermal Cyst

Name

Location

Atlanta Va Medical Center Decatur, Georgia  30033