Evaluation of Healing at Three Time Intervals and Potential for Spontaneous Detachment

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

Conditions

• Male Circumcision

Interventions

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. 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

Sponsors & Collaborators

• Kenya National AIDS & STI Control Programme

  collaborator OTHER

• Ministry of Medical Services, Kenya

  collaborator OTHER

• EngenderHealth

  collaborator OTHER

• Cornell University

  collaborator OTHER

• FHI 360

  lead OTHER

Principal Investigators

• Marc Goldstein, M.D. · Weill Cornell Medical College, NY, USA

• Mark Barone, DVM; MS · EngenderHealth, NY, USA

• Philip S. Li, MD · Weill Medical College of Cornell University

• Puneet Masson, MD · Weill Medical College of Cornell University

• Paul Perchal, MA · EngenderHealth

• Jared Moguche, MB ChB · EngenderHealth

• Quentin Awori, MB ChB · Engender Health

• Peter Cherutich, MB ChB MPH · National AIDS/STD Control Programme, Nairobi, Kenya

• Nicholas Muraguri, MB ChB MPH · National AIDS/STD Control Programme

• John Masasabi Wekesa, MB ChB MMed · Ministry of Medical Services Nairobi Kenya

• Robert Otieno Simba, MMed · Homa Bay District Hospital

Study Design

Allocation

RANDOMIZED

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

54 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-09-30

Primary Completion

2011-01-31

Completion

2011-01-31

Countries

• Kenya

Study Locations