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

NCT ID: NCT00165958

Last Updated: 2014-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2011-07-31

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

Conditions

Epidermal Cyst

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Punch excision

Group Type: EXPERIMENTAL

Punch incision of epidermal cyst

Intervention Type: PROCEDURE

removal of cyst first with incisional effort with a punch biopsy tool

Traditional excision

Group Type: ACTIVE_COMPARATOR

Excisional surgery of epidermal cyst

Intervention Type: PROCEDURE

Traditional extirpation of cyst en toto

Interventions

Excisional surgery of epidermal cyst

Traditional extirpation of cyst en toto

Intervention Type: PROCEDURE

Punch incision of epidermal cyst

removal of cyst first with incisional effort with a punch biopsy tool

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Suephy Chen, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Suephy C Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University Department of Dermatology

Locations

Atlanta VA Medical Center

Decatur, Georgia, United States

Countries

United States

Other Identifiers

1023-2004

Identifier Type: -

Identifier Source: org_study_id