Mohamad Salleh bin Abdul Aziz
Cyberjaya University College Of Medical Science, Malaysia
Title: A safe, easy and effective disposable circumcision device: A pilot study clinical study in Malaysia and Indonesia
Biography
Biography: Mohamad Salleh bin Abdul Aziz
Abstract
Introduction: Solehring is a newly created disposable circumcision device. The design and concept are similar to Plastibell using surgical suture to and compress the blood vessel followed by cutting of the skin using surgical scissors. The ring will fall off from the skin within 10 to 14 days by concept of iscahemic-necrosis. The skin and mucosa part of penis will automatically healed by secondary intention.
Objective(s): The study was performed to identify and assess the safety of the device for circumcision in children.
Methodologies: A pilot clinical study was successfully conducted in Malaysia and Indonesia when conducting circumcision in children between the age of 7 to 12 years old with following end-points: Major adverse event, average pain score using visual analogue score, pain and swelling related with allergic reaction, bleeding during and post circumcision, infection rate and the drop off day (12).
Results: Out of 19 subjects who offered solehring circumcision procedure, 15 were able to complete circumcision technically. No major adverse events were reported. The drop off day was reported at day 10 (46.67%) and the latest is day 14 (13.33%). Average pain score was recorded as minimum as 2 out of 10 (26.67%). Only one child reported to have average pain score at 5/10.
Discussion: The study results from 3 different areas showed no major adverse events from 15 subjects. However, the sample size is inadequate to conclude the easy and effective disposable circumcision device. We encourage further study with larger sample size to assess the easy and effectiveness of the device.
Conclusion: Solehring is a safe device for circumcision in children.