Evaluation of Healing at Three Time Intervals and Potential for Spontaneous Detachment
Condition: Male Circumcision
Study type: Interventional

Summary: 
      The objective of this research study is to evaluate the safety and acceptability of the Shang
      Ring method of medical male circumcision. The Shang Ring is a new circumcision device with a
      potential role in the safe and cost-effective delivery of circumcision services. The device,
      developed in China, consists of two concentric plastic rings. Following a ring penile block,
      the smaller ring is fitted at the base of the coronal sulcus. The foreskin is everted over
      the inner ring and the larger outer ring is secured over the inner ring. The foreskin is
      excised and several nicks are made on the incision line to prevent formation of a
      constricting, circumferential scab. No suturing is required.

      In this study, the investigators will evaluate wound healing of men randomized to removal of
      the Shang Ring at one of three different points in time (Days 7, 14 or 21). Leaving the
      device on for 14 or 21 days constitutes extended wear of the device.

      Sites: Homa Bay District Hospital, Nyanza Province, Kenya
    

Detailed description: 
      The objective of this research study is to evaluate the safety and acceptability of the Shang
      Ring method of medical male circumcision. The Shang Ring is a new circumcision device with a
      potential role in the safe and cost-effective delivery of circumcision services. The device,
      developed in China, consists of two concentric plastic rings. Following a ring penile block,
      the smaller ring is fitted at the base of the coronal sulcus. The foreskin is everted over
      the inner ring and the larger outer ring is secured over the inner ring. The foreskin is
      excised and several nicks are made on the incision line to prevent formation of a
      constricting, circumferential scab. No suturing is required.

      In this study, we will evaluate wound healing of men randomized to removal of the Shang Ring
      at one of three different points in time (Days 7, 14 or 21). Leaving the device on for 14 or
      21 days constitutes extended wear of the device.

      Although male circumcision has a demonstrated protective effect against HIV transmission,
      currently available surgical techniques and devices have limitations for widespread
      deployment in resource-poor areas. High costs and scarcity of trained providers hinder access
      to male circumcision services in resource-poor areas. Its simple design sets the Shang Ring
      apart from other male circumcision techniques. The Shang Ring has the potential for safe,
      effective and inexpensive delivery of male circumcision by trained healthcare personnel in
      HIV endemic countries.
    

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. The man must return to the clinic for device removal. To remove the device, the outer ring locking mechanism is 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: adult Males; circumcision; HIV prevention; device