Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00165958
Recruitment Status : Completed
First Posted : September 14, 2005
Results First Posted : August 4, 2014
Last Update Posted : August 4, 2014
Sponsor:
Information provided by (Responsible Party):
Suephy Chen, MD, Emory University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Epidermal Cyst Procedure: Excisional surgery of epidermal cyst Procedure: Punch incision of epidermal cyst Phase 4

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

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Excision Versus Punch Incision in the Treatment of Epidermal Cysts
Study Start Date : January 2005
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2011
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Punch excision Procedure: Punch incision of epidermal cyst
removal of cyst first with incisional effort with a punch biopsy tool
Active Comparator: Traditional excision Procedure: Excisional surgery of epidermal cyst
Traditional extirpation of cyst en toto


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of Participants With Cyst Recurrence [ Time Frame: 16 months ]
    Recurrence of cyst after removal


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00165958


Locations
Layout table for location information
United States, Georgia
Atlanta VA Medical Center
Decatur, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Layout table for investigator information
Principal Investigator: Suephy C Chen, MD Emory University Department of Dermatology
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Suephy Chen, MD, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT00165958    
Other Study ID Numbers: 1023-2004
First Posted: September 14, 2005    Key Record Dates
Results First Posted: August 4, 2014
Last Update Posted: August 4, 2014
Last Verified: July 2014
Keywords provided by Suephy Chen, MD, Emory University:
Epidermal cyst
Epidermoid cyst
Sebaceous cyst
Pilar cyst
Additional relevant MeSH terms:
Layout table for MeSH terms
Cysts
Epidermal Cyst
Neoplasms
Pathological Conditions, Anatomical