title: 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.
  
  
  METHODS
  Prospective pilot trial of a novel surgical device.
  
  
  METHODS
  Tertiary care Veterans Administration medical center.
  
  
  METHODS
  Five adult males.
  
  
  METHODS
  Circumcisions performed by junior trainees using an adjustable, single-size surgical-assist device constructed by the University of Washington Applied Physics Laboratory.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  This proof-of-study suggests that the Simple Circumcision Device may facilitate delivery of safe adult male circumcision services.
authors.affiliation: Department of Urology, University of Washington Medical Center, Seattle, Washington; Veterans Administration Puget Sound Health Care System, Seattle, Washington. Electronic address: jim.hotaling@hsc.utah.edu.
authors.forename: James M
authors.initials: JM
authors.lastname: Hotaling
authors.affiliation: Department of Urology, University of Washington Medical Center, Seattle, Washington; Veterans Administration Puget Sound Health Care System, Seattle, Washington.
authors.forename: Laura S
authors.initials: LS
authors.lastname: Leddy
authors.affiliation: Department of Urology, University of Washington Medical Center, Seattle, Washington; Veterans Administration Puget Sound Health Care System, Seattle, Washington.
authors.forename: Mahum A
authors.initials: MA
authors.lastname: Haider
authors.affiliation: Department of Urology, University of Washington Medical Center, Seattle, Washington; Veterans Administration Puget Sound Health Care System, Seattle, Washington.
authors.forename: Matthew
authors.initials: M
authors.lastname: Mossanen
authors.affiliation: Veterans Administration Puget Sound Health Care System, Seattle, Washington; Applied Physics Laboratory, University of Washington, Seattle, Washington.
authors.forename: Michael R
authors.initials: MR
authors.lastname: Bailey
authors.affiliation: Applied Physics Laboratory, University of Washington, Seattle, Washington.
authors.forename: Brian
authors.initials: B
authors.lastname: MacConaghy
authors.affiliation: Applied Physics Laboratory, University of Washington, Seattle, Washington.
authors.forename: Francis
authors.initials: F
authors.lastname: Olson
authors.affiliation: Department of Urology, University of Washington Medical Center, Seattle, Washington; Veterans Administration Puget Sound Health Care System, Seattle, Washington.
authors.forename: John N
authors.initials: JN
authors.lastname: Krieger
mesh_terms: D000328:Adult; D002944:Circumcision, Male / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods*; D004867:Equipment Design / Q000295:instrumentation*; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D061646:Operative Time; D061214:Patient Safety; D010865:Pilot Projects; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome
keywords: AIDS; HIV; circumcision; surgical device