A Prospective Field Study: Introducing the Shang Ring in Routine Clinical Settings
Condition: Male Circumcision
Study type: Interventional
Phase: Phase 4

Summary: 
      Male Circumcision (MC) is the only new biomedical method to demonstrate consistent efficacy
      as an HIV prevention intervention in randomized controlled trials (WHO and UNAIDS, 2007),
      based on three randomized controlled trials in Kenya, Uganda, and South Africa, that reported
      a protective effect of about 60%
    

Detailed description: 
      The World Health Organization, the Joint United Nations Programme on HIV/AIDS (UNAIDS), and
      other global reproductive health organizations have recognized the highly protective effect
      of male circumcision to prevent HIV infection in men. Male Circumcision (MC) is the only new
      biomedical method to demonstrate consistent efficacy as an HIV prevention intervention in
      randomized controlled trials, based on three randomized controlled trials in Kenya, Uganda,
      and South Africa, that reported a protective effect of about 60%. Subsequent studies have
      confirmed the value and persistence of MC's protection against HIV infection, and have
      demonstrated that MC also reduces the transmission of human papillomavirus.

      A wide variety of instruments, devices, and techniques are used around the world for male
      circumcision. The WHO, UNAIDS and JHPIEGO document entitled Manual for Male Circumcision
      under Local Anesthesia, includes step-by-step instructions for performing adult male
      circumcision using three different surgical procedures: the forceps-guided, dorsal slit, and
      sleeve resection methods. Procedure times for these techniques are approximately 20-30
      minutes excluding anesthesia and involve control of unavoidable bleeding and a significant
      amount of suturing, and can be associated with complications that include hematoma formation,
      infection, unsatisfactory cosmetic result, lacerations of the penile or scrotal skin and
      injury to the glans, particularly among inexperienced surgeons. Although training is
      necessary regardless of method, devices for MC have the potential to reduce both training
      time and surgical duration because neither hemostasis nor suturing is needed for most
      devices.

      The Shang Ring is an innovative device for adult male circumcision that has been on the
      Chinese market since 2005. The Shang Ring is manufactured by Wuhu SNNDA Medical Treatment
      Appliance Technology Co., Ltd (SNNDA).

      In the current African setting, only surgical circumcision is available for adults. Devices
      such as the Shang Ring have the potential to simplify and shorten surgery by eliminating the
      need for suturing and hemostasis. Data from two small studies in Kenya suggest that the Shang
      Ring has an acceptable safety profile. A randomized controlled trial was conducted in Kenya
      and Zambia to provide further data.

      Circumcision using the Shang Ring involves a few simple steps. First, a special measuring
      strip is used to determine which Shang Ring size to use. Following administration of local
      anesthesia, the inner ring is fitted at the base of the glans penis. Next, the foreskin is
      everted over the inner ring and the outer ring is secured (locked) over the inner ring, thus
      encasing the foreskin. The sterile device forms a tight seal. The foreskin is excised and
      several nicks are made in the foreskin on the underside of the device to prevent formation of
      a stiff, circumferential scab. Bleeding is minimal and no suturing or hemostasis is required.
      Finally, the participant returns in seven days for removal of the Shang Ring device. After
      removal, a bandage is applied to the wound. Men may be given a supply of bandages and told to
      change the bandaging daily or as needed.
    

Intervention name(s): Shang Ring
Intervention type(s): Device
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 scissors is used to remove the inner ring, and a bandage or gauze dressing is applied.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention