A Prospective Field Study: Introducing the Shang Ring in Routine Clinical Settings
|ClinicalTrials.gov Identifier: NCT01567436|
Recruitment Status : Completed
First Posted : March 30, 2012
Last Update Posted : September 27, 2012
|Condition or disease||Intervention/treatment||Phase|
|Male Circumcision||Device: Shang Ring||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Study of Male Circumcision Using the Shang Ring in Routine Clinical Settings in Kenya & Zambia|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||August 2012|
Device: Shang Ring
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 42 days ]
- Acceptability of the Shang Ring Procedure [ Time Frame: 42 days ]
- Percentage of men completely healed at 42 days [ Time Frame: 42 Days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01567436
|Homa Bay District Hospital male circumcision clinic|
|Homa Bay, Nyanza, Kenya, 40300|
|Society for Family Planning Clinic|
|Study Chair:||Marc Goldstein, M.D.||Weill Cornell Medical College, NY, USA|
|Study Chair:||Mark A Barone, DVM, MS||EngenderHealth, NY, USA|
|Principal Investigator:||Philip S Li, MD||Weill Cornell Medical College, NY, USA|
|Principal Investigator:||Richard Lee, MD||Weill Cornell Medical College, NY, USA|
|Principal Investigator:||Paul Perchal, MA||EngenderHealth, NY, USA|
|Principal Investigator:||Jared Mogouche, MD ChB||EngenderHealth, Kisumu, Kenya|
|Principal Investigator:||Quentin Awori, MB ChB||EngenderHealth, Homa Bay, Kenya|
|Principal Investigator:||Raymond Simba, MB ChB MPH||Homa Bay District Hospital, Ministry of Health, Homa Bay, Kenya|
|Principal Investigator:||Nicholas Muraguri, MB ChB MPH||National AIDS/STD Control Programme, Nairobi, Kenya|
|Principal Investigator:||John M Wekesa, MB ChB MMed||Ministry of Medical Services, Nairobi, Kenya|
|Principal Investigator:||Kasonde Bowa, MSc M. Med FRCS FACS FCS||University of Zambia|
|Principal Investigator:||Robert Zulu, MD||University Teaching Hospital, Lusaka, Zambia|