- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00165958
Comparison of Excision Versus Punch Incision in the Treatment of Epidermal Cysts
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Georgia
-
Decatur, Georgia, United States, 30322
- Atlanta VA Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Punch excision
|
removal of cyst first with incisional effort with a punch biopsy tool
|
Active Comparator: Traditional excision
|
Traditional extirpation of cyst en toto
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Cyst Recurrence
Time Frame: 16 months
|
Recurrence of cyst after removal
|
16 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Suephy C Chen, MD, Emory University Department of Dermatology
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1023-2004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Epidermal Cyst
-
Goldman, Butterwick, Fitzpatrick and GroffNot yet recruitingEpidermoid Cyst
-
Isfahan University of Medical SciencesCompletedDermoid Cyst of Orbit
-
West China HospitalRecruitingInfantile Hemangiomas | Neck Mass | Thyroglossal Duct Cysts | Branchial Cleft Anomalies | Dermoid and Epidermoid Cysts | TeratomasChina
-
Vanderbilt University Medical CenterCompletedPlaque Psoriasis | Morphea | Alopecia Areata | Acne | Lichen Planus | Keloid | Prurigo Nodularis | Hypertrophic Scar | Frontal Fibrosing Alopecia | Keratoacanthoma | Granuloma Annulare | Nummular Eczema | Lichen Simplex Chronicus | Lichen Plano-Pilaris | Epidermal Inclusion CystUnited States
-
Atlantia Food Clinical TrialsCompleted
-
Erzurum Regional Training & Research HospitalCompletedKnee Disease | Baker Cyst
-
Cynosure, Inc.CompletedEpidermal Pigmented Lesions | Skin ToningUnited States
-
Cynosure, Inc.CompletedDermal and Epidermal Pigmented LesionsUnited States
-
Balnear and Rehabilitation Sanatorium TechirghiolCompletedKnee Osteoarthritis | Baker CystRomania
Clinical Trials on Punch incision of epidermal cyst
-
Shiraz University of Medical SciencesShahid Beheshti University of Medical SciencesCompletedJaw, Edentulous, PartiallyIran, Islamic Republic of
-
Postgraduate Institute of Medical Education and...Unknown
-
University of PittsburghVA Pittsburgh Healthcare System; American Society for Gastrointestinal EndoscopyCompletedPancreatic Cyst | Pancreatic Neoplasm | Pancreatic PseudocystUnited States
-
Jaehwan KimNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and other collaboratorsRecruiting
-
Isfahan University of Medical SciencesCompletedDermoid Cyst of Orbit
-
National Taiwan University HospitalCompleted
-
VANBIERVLIETActive, not recruiting
-
Hillel Yaffe Medical CenterUnknown
-
Institute of Dermatology, ThailandChumsaeng ChumsaengsriActive, not recruiting
-
Al-Azhar UniversityActive, not recruiting