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

Epidermal Cyst Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00165958
• Other study ID #: 1023-2004
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: July 11, 2014
• Start date: January 2005
• Est. completion date: July 2011

Study information

• Verified date: July 2014
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2011
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cysts
• Epidermal Cyst

Intervention

Procedure:
• Excisional surgery of epidermal cyst
Traditional extirpation of cyst en toto
• Punch incision of epidermal cyst
removal of cyst first with incisional effort with a punch biopsy tool

Locations

Country	Name	City	State
United States	Atlanta VA Medical Center	Decatur	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Cyst Recurrence	Recurrence of cyst after removal	16 months	No