Comparison of the Shang Ring With Conventional Surgical Methods
Condition: Circumcision, Male
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Intervention name(s): Shang Ring; Male circumcision
Intervention type(s): Device; Procedure
Intervention description(s): 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; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adult Males; Circumcision; HIV prevention; Device; Shang Ring