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

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

Study Overview

• Status: Completed
• Conditions: Male Circumcision
• Intervention / Treatment: Device: Shang Ring

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Nyanza
    • Homa Bay, Nyanza, Kenya, 40300
      • Homa Bay District Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 52 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Must be aged 18 and 54 years;
• Must be uncircumcised (on examination);
• Must be in good general health;
• Must be HIV sero-negative, with documentation of testing no mor than one week before the procedure;
• Must be free of genital ulcerations or other visible signs of sexually transmissible infections(STI) on examination;
• Must be able to understand study procedures and requirements of study participation;
• Must agree to return to the healthcare facility for the full schedule of follow-up visits after his circumcision;
• Must freely consent to participate in the study and sign a written informed consent form;
• Must have a cell phone or access to a cell phone; and,
• Must agree to provide the study staff with an address, phone number, or other locator information while participating in the research study.

Exclusion Criteria:

• Has a known allergy or sensitivity to lidocaine or other local anesthesia;
• Takes a medication that would be a contraindication for elective surgery, such as an anticoagulant or steroid;
• Has an active genital infection, anatomic abnormality or other condition, which in the opinion of the surgeon, prevents the man from undergoing a circumcision;
• Has known bleeding/clotting disorder (e.g. hemophilia); and,
• Has thalassemia (an inherited autosomal recessive blood disease).

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Day 7; removal of Shang Ring at 7 days	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
Other: Day 14; removal of Shang Ring at 14 days	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
Other: Day 21; removal of Shang Ring at 21 days	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asses healing time	Assess healing time from date of circumcision	six weeks
spontaneous detachment of device	Spontaneous detachment from date of circumcision to three weeks post procedure	21 days

Collaborators and Investigators

• Sponsor: FHI 360
• Collaborators: Cornell University; EngenderHealth; Kenya National AIDS & STI Control Programme; Ministry of Medical Services, Kenya
• Investigators: Study Chair: Marc Goldstein, M.D., Weill Cornell Medical College, NY, USA; Study Chair: Mark Barone, DVM; MS, EngenderHealth, NY, USA; Principal Investigator: Philip S. Li, MD, Weill Medical College of Cornell University; Principal Investigator: Puneet Masson, MD, Weill Medical College of Cornell University; Principal Investigator: Paul Perchal, MA, EngenderHealth; Principal Investigator: Jared Moguche, MB ChB, EngenderHealth; Principal Investigator: Quentin Awori, MB ChB, Engender Health; Principal Investigator: Peter Cherutich, MB ChB MPH, National AIDS/STD Control Programme, Nairobi, Kenya; Principal Investigator: Nicholas Muraguri, MB ChB MPH, National AIDS/STD Control Programme; Principal Investigator: John Masasabi Wekesa, MB ChB MMed, Ministry of Medical Services Nairobi Kenya; Principal Investigator: Robert Otieno Simba, MMed, Homa Bay District Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: September 7, 2010
• First Submitted That Met QC Criteria: November 23, 2010
• First Posted (Estimate): November 24, 2010

Study Record Updates

• Last Update Posted (Estimate): March 6, 2015
• Last Update Submitted That Met QC Criteria: March 4, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: HIV prevention; device; circumcision; adult Males
• Other Study ID Numbers: 10214 (Other Identifier: CTEP)