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

Primary Purpose

Epidermal Cyst

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Excisional surgery of epidermal cyst
Punch incision of epidermal cyst
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epidermal Cyst focused on measuring Epidermal cyst, Epidermoid cyst, Sebaceous cyst, Pilar cyst

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Atlanta VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Punch excision

Traditional excision

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With Cyst Recurrence
Recurrence of cyst after removal

Secondary Outcome Measures

Full Information

First Posted
September 12, 2005
Last Updated
July 11, 2014
Sponsor
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT00165958
Brief Title
Comparison of Excision Versus Punch Incision in the Treatment of Epidermal Cysts
Official Title
Comparison of Excision Versus Punch Incision in the Treatment of Epidermal Cysts
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epidermal Cyst
Keywords
Epidermal cyst, Epidermoid cyst, Sebaceous cyst, Pilar cyst

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Punch excision
Arm Type
Experimental
Arm Title
Traditional excision
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Excisional surgery of epidermal cyst
Intervention Description
Traditional extirpation of cyst en toto
Intervention Type
Procedure
Intervention Name(s)
Punch incision of epidermal cyst
Intervention Description
removal of cyst first with incisional effort with a punch biopsy tool
Primary Outcome Measure Information:
Title
Number of Participants With Cyst Recurrence
Description
Recurrence of cyst after removal
Time Frame
16 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suephy C Chen, MD
Organizational Affiliation
Emory University Department of Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atlanta VA Medical Center
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

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

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