NCT01300910

Comparison of the Shang Ring With Conventional Surgical Methods

Comparison of the Shang Ring With Conventional Surgical Methods: A Randomized Controlled Trial

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: FHI 360 · Academic / Other
• Sex: Male
• Age: 18 Years – 54 Years
• Healthy volunteers: Accepted

Summary

This is a randomized control trial of 400 adult male circumcision procedures with a one to one ratio between Shang Ring and the in-country standard surgical technique (forceps guided in Kenya and dorsal slit in Zambia).

Detailed description

A randomized control trial of 400 adult male circumcision procedures with a one to one ratio between Shang Ring and the in-country standard surgical technique (forceps guided in Kenya and dorsal slit in Zambia) Population: 400 men (200 at each site), HIV sero-negative men, ages 18-54, living in/around the two clinic sites seeking adult male circumcision Duration: 2-4 months of recruitment; 60 days follow-up per participant; total expected duration of approximately 6 months in the field Primary Objectives: (1) Compare the pain and acceptability of the Shang Ring procedure with the forceps guided surgical circumcision technique (Kenya) and the dorsal slit technique (Zambia) (2) Compare the safety and the course of wound healing, including the time to complete healing, between the Shang Ring adult male circumcision procedure and the standard surgical circumcision procedures (forceps guided in Kenya \& dorsal slit in Zambia); (3) Compare the ease of the Shang Ring method versus standard circumcision surgical procedures Primary Endpoints: (1) To compare the pain \& acceptability of the circumcision methods, we will evaluate the following: post-operative pain; time to return to normal activity; patients' opinions of the Shang Ring and conventional procedures, and satisfaction with cosmetic results. (2) To compare safety between methodologies, we will clinically compare and evaluate related adverse events and their severity. We will also compare the time to complete wound healing for each method. Complete wound healing is defined as no scab and dry skin by clinical assessment. (3) We will evaluate the ease of surgery based on the duration of surgery and surgeons' opinions.

Conditions

• Circumcision, Male

Interventions

Type	Name	Description
DEVICE	Shang Ring	The Shang Ring is a sterile device consisting of two concentric medical grade plastic rings: an inner ring with a silicone band and an outer, hinged ring. The inner ring fits inside the outer ring which will lock when snapped together. The Shang Ring comes in multiple sizes. The appropriate size is determined through use of a measuring strip. To ensure that men cannot remove the device prematurely, the locking mechanism must be broken open using a tool that is similar to a scalpel handle. Then, a pair of special scissors, specifically designed for this purpose, is used to remove the inner ring after healing
PROCEDURE	Male circumcision	A conventional surgical procedure will be performed, per WHO recommendations, involving: drawing a line to mark the amount of foreskin to be cut; cutting off the foreskin; hemostasis; and wound closure with sutures.

Timeline

• Start date: 2011-02-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2011-02-23
• Last updated: 2012-03-16

Locations

2 sites across 2 countries: Kenya, Zambia