Safe Circumcision
Conditions
Keywords
circumcision, HIV prevention
Brief summary
The investigators are testing a novel surgical device to facilitate safe circumcision among adult males. The investigators hypothesize that this device will allow non-medical providers to perform safe surgical circumcision without adverse events.
Detailed description
Objective: To conduct a proof-of-concept study to determine the potential utility of a novel, adjustable single-visit, disposable device to facilitate rapid adult circumcision. Design: Prospective pilot trial of a novel surgical device Setting: Tertiary care Veterans Administration medical center Patients: 5 adult males Interventions: Circumcisions performed by junior trainees using an adjustable, single-size surgical-assist device constructed by the University of Washington Applied Physics Laboratory. Main Outcome Measure(s): The attending surgeon and trainees completed standardized forms after each procedure to assess technical problems and ease of use. Follow-up visits were scheduled to evaluate adverse events, post-operative pain, cosmetic outcomes and participant satisfaction at 3, 8, 30 and 90 days post-operatively.
Interventions
PROCEDUREcircumcision with simple circumcision device
Circumcision performed with the device in the operating room using local anesthesia
Sponsors
University of Washington
VA Puget Sound Health Care System
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Inclusion 1. Uncircumcised males 2. Aged\>18 3. Sexually active 4. No plans for moving in next 6 months 5. Consent to participate Exclusion 1. History of a bleeding disorder 2. History of a documented concurrent STI of appearance of an STI on initial physical exam 3. Keloid formation or other condition that might unduly increase risk of elective surgery 4. Asprin, anti-coagulants or other clinical contra-indications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy, injury rate, conversion to standard method rate and cosmetic outcomes of novel surgical device | 90 days | To determine if the novel surgical device was able to facilitate safe circumcision among adult males. Specifically we looked at: time of surgery, blood loss, ease of use, cosmetic outcome, number of sutures required, need for conversion to another method of circumcision and need for revision surgeries. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time of circumcision | 1 day | To determine how long the operative procedure required to complete |
Countries
United States
Outcome results
None listed