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| Sponsor: | Emory University |
|---|---|
| Information provided by: | Emory University |
| ClinicalTrials.gov Identifier: | NCT00165958 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Epidermal Cyst |
Procedure: Excisional surgery of epidermal cyst Procedure: Punch incision of epidermal cyst |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment |
| Official Title: | Comparison of Excision Versus Punch Incision in the Treatment of Epidermal Cysts |
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2005 |
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Suephy C Chen, MD | 404-778-3084 | schen2@emory.edu |
| Contact: Bridget Bradley, RN | 404-778-3084 | brbradl@emory.edu |
| United States, Georgia | |
| Atlanta Veteran's Administration Medical Center | Recruiting |
| Decatur, Georgia, United States, 30033 | |
| Contact: Ronald A Schuchard, PhD 404-728-5063 rschuch@emory.edu | |
| Contact: Michelle Harper 404-728-4827 Katherine.Harper@med.va.gov | |
| Principal Investigator: Suephy C Chen, MD | |
| Sub-Investigator: Jamie MacKelfresh, MD | |
| Principal Investigator: | Suephy C Chen, MD | Emory University Department of Dermatology |
More Information
| ClinicalTrials.gov Identifier: | NCT00165958 History of Changes |
| Other Study ID Numbers: | 1023-2004 |
| Study First Received: | September 12, 2005 |
| Last Updated: | September 12, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
Epidermal cyst Epidermoid cyst Sebaceous cyst Pilar cyst |
|
Cysts Epidermal Cyst Neoplasms Pathological Conditions, Anatomical |
