Comparison of the Shang Ring With Conventional Surgical Methods

Circumcision, Male Clinical Trial

Official title:

Comparison of the Shang Ring With Conventional Surgical Methods: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01300910
• Other study ID #: 10220
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 7, 2010
• Last updated: March 15, 2012
• Start date: February 2011
• Est. completion date: June 2011

Study information

• Verified date: March 2012
• Source: FHI 360
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Instititional Review BoardKenya: National Institutional Review BoardZambia: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is a randomized control trial of 400 adult male circumcision procedures with a one to one ratio between Shang Ring and the in-country standard surgical technique (forceps guided in Kenya and dorsal slit in Zambia).

Description:

A randomized control trial of 400 adult male circumcision procedures with a one to one ratio between Shang Ring and the in-country standard surgical technique (forceps guided in Kenya and dorsal slit in Zambia)

Population: 400 men (200 at each site), HIV sero-negative men, ages 18-54, living in/around the two clinic sites seeking adult male circumcision

Duration: 2-4 months of recruitment; 60 days follow-up per participant; total expected duration of approximately 6 months in the field

Primary Objectives: (1) Compare the pain and acceptability of the Shang Ring procedure with the forceps guided surgical circumcision technique (Kenya) and the dorsal slit technique (Zambia) (2) Compare the safety and the course of wound healing, including the time to complete healing, between the Shang Ring adult male circumcision procedure and the standard surgical circumcision procedures (forceps guided in Kenya & dorsal slit in Zambia); (3) Compare the ease of the Shang Ring method versus standard circumcision surgical procedures

Primary Endpoints: (1) To compare the pain & acceptability of the circumcision methods, we will evaluate the following: post-operative pain; time to return to normal activity; patients' opinions of the Shang Ring and conventional procedures, and satisfaction with cosmetic results.

(2) To compare safety between methodologies, we will clinically compare and evaluate related adverse events and their severity. We will also compare the time to complete wound healing for each method. Complete wound healing is defined as no scab and dry skin by clinical assessment.

(3) We will evaluate the ease of surgery based on the duration of surgery and surgeons' opinions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 54 Years

Eligibility

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 more than one week before the procedure;

• Must be free of genital ulcerations or other visible signs of 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 known bleeding/clotting disorder (e.g. hemophilia); or

• Has an active genital infection, anatomic abnormality or other condition (e.g. severe obesity, diabetes or sickle cell anemia), which in the opinion of the surgeon, prevents the man from undergoing a circumcision as part of this study;

• Is not currently participating in another biomedical study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Circumcision, Male

Intervention

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. 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 special scissors, specifically designed for this purpose, is used to remove the inner ring after healing

Procedure:
• Male circumcision
A conventional surgical procedure will be performed, per WHO recommendations, involving: drawing a line to mark the amount of foreskin to be cut; cutting off the foreskin; hemostasis; and wound closure with sutures.

Locations

Country	Name	City	State
Kenya	Homa Bay District Hospital male circumcision clinic	Homa Bay	Nyanza
Zambia	Society for Family Planning Clinic	Lusaka

Sponsors (6)

Lead Sponsor	Collaborator
FHI 360	EngenderHealth, Kenya National AIDS & STI Control Programme, Ministry of Medical Services, Kenya, University Teaching Hospital, Lusaka, Zambia, Weill Medical College of Cornell University

Countries where clinical trial is conducted

Kenya,  Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain scores on the Visual Analog Scale	We will ask participants about pain they experienced during and soon after the procedure, and during the recovery period.	Within the first 48 hours after circumcision	Yes
Primary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	We will classify circumcision-related adverse events, using the detailed definitions of moderate and severe events per standardized protocol definitions, based on WHO recommendations. Most post-operative complications are apparent within six weeks of surgery.	Up to six weeks after surgery	Yes
Secondary	Compare the cost of the Shang Ring procedure versus conventional surgery		Three months	No