Comparison of the Shang Ring With Conventional Surgical Methods

Status Completed

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).

Clinical Trial 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. ;

Study Design

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

Related Conditions & MeSH terms

Circumcision, Male

Clinical Trial Details

NCT number	NCT01300910
Study type	Interventional
Source	FHI 360
Contact
Status	Completed
Phase	Phase 2/Phase 3
Start date	February 2011
Completion date	June 2011

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.