Trial Outcomes & Findings for Comparison of Excision Versus Punch Incision in the Treatment of Epidermal Cysts (NCT NCT00165958)

NCT ID: NCT00165958

Last Updated: 2014-08-04

Results Overview

Recurrence of cyst after removal

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 40 participants
• Primary outcome timeframe: 16 months
• Results posted on: 2014-08-04

Participant Flow

subjects older than 18 years of age with 1-3 cm truncal EICs were selected via serial recruitment from the Atlanta Veterans Affairs Medical Center Dermatology clinic

Patients were excluded if the cysts were inflamed, infected, or ruptured based on characteristic physical examination findings.

Participant milestones

Measure	Punch Excision Punch incision of epidermal cyst : removal of cyst first with incisional effort with a punch biopsy tool	Traditional Excision Excisional surgery of epidermal cyst : Traditional extirpation of cyst en toto
Overall Study STARTED	19	21
Overall Study COMPLETED	18	19
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Punch Excision n=19 Participants Punch incision of epidermal cyst : removal of cyst first with incisional effort with a punch biopsy tool	Traditional Excision n=21 Participants Excisional surgery of epidermal cyst : Traditional extirpation of cyst en toto	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=93 Participants	16 Participants n=4 Participants	30 Participants n=27 Participants
Age, Categorical >=65 years	5 Participants n=93 Participants	5 Participants n=4 Participants	10 Participants n=27 Participants
Age, Continuous	60.3 years STANDARD_DEVIATION 11.8 • n=93 Participants	59.0 years STANDARD_DEVIATION 9.9 • n=4 Participants	59.6 years STANDARD_DEVIATION 10.7 • n=27 Participants
Sex: Female, Male Female	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Sex: Female, Male Male	18 Participants n=93 Participants	19 Participants n=4 Participants	37 Participants n=27 Participants
Region of Enrollment United States	19 participants n=93 Participants	21 participants n=4 Participants	40 participants n=27 Participants

PRIMARY outcome

Timeframe: 16 months

Recurrence of cyst after removal

Outcome measures

Measure	Punch Incision n=19 Participants Punch incision of epidermal cyst : removal of cyst first with incisional effort with a punch biopsy tool	Traditional Excision n=17 Participants Excisional surgery of epidermal cyst : Traditional extirpation of cyst en toto
Number of Participants With Cyst Recurrence	3 participants	2 participants

Adverse Events

Punch Incision

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Traditional Excision

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Suephy Chen

Emory University

Phone: 4047783084

Email: schen2@emory.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place