Simple circumcision device: proof of concept for a single-visit, adjustable device to facilitate safe adult male circumcision.

ABSTRACT

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. PATIENT(S) Five adult males. INTERVENTION(S) 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, postoperative pain, cosmetic outcomes, and participant satisfaction at 3, 8, 30, and 90 days postoperatively. RESULT(S) The average operative time was 16.4 minutes. All cases were performed with local anesthesia, and no case required electrocautery or conversion to standard surgery. At the postoperative day 3 visit, all subjects were happy with their results and would recommend the procedure to another patient. One participant had a minor wound separation noted at the 30-day visit that resolved during follow-up. There were no wound infections, hematomas, or other adverse events. CONCLUSION(S) This proof-of-study suggests that the Simple Circumcision Device may facilitate delivery of safe adult male circumcision services.