Comparison of the Shang Ring With Conventional Surgical Methods

NCT01300910 | Completed Phase 2 DMC

• 1 other identifier: 10220
• Study Type: interventional
• Target: 400
• Locations: 2 countries
• Sites: 2

Brief 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).

Conditions

Circumcision, Male

Keywords

Adult Males; Circumcision; HIV prevention; Device; Shang Ring

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (1)

• Compare the cost of the Shang Ring procedure versus conventional surgery

  Three months

Study Arms (2)

1

ACTIVE COMPARATOR

One group of men will undergo a circumcision using the Shang Ring and men are to return for regular follow-up visits to evaluate pain and wound healing. . The Shang Ring will be removed at 7 days, and the last scheduled follow-up visit is at 60 days.

Device: Shang Ring

2

ACTIVE COMPARATOR

One group of men will undergo a conventional circumcision using a WHO recommended surgical technique, either the forceps-guided method or the dorsal slit method. Men are to return for regular follow-up visits to evaluate pain and wound healing, with the last scheduled follow-up visit at 60 days.

Procedure: Male circumcision

Interventions

Shang Ring DEVICE

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

1

Male circumcision PROCEDURE

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.

2

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• FHI 360: lead
• EngenderHealth: collaborator
• Weill Medical College of Cornell University: collaborator
• Kenya National AIDS & STI Control Programme: collaborator
• Ministry of Medical Services, Kenya: collaborator
• University Teaching Hospital, Lusaka, Zambia: collaborator

Study Sites (2)

Homa Bay District Hospital male circumcision clinic

Homa Bay, Nyanza, 40300, Kenya

Location

Society for Family Planning Clinic

Lusaka, Zambia

Location

Related Publications (1)

• Hohlfeld A, Ebrahim S, Shaik MZ, Kredo T. Circumcision devices versus standard surgical techniques in adolescent and adult male circumcisions. Cochrane Database Syst Rev. 2021 Mar 31;3(3):CD012250. doi: 10.1002/14651858.CD012250.pub2.

  PMID: 33786810 DERIVED

MeSH Terms

Interventions

Circumcision, Male

Intervention Hierarchy (Ancestors)

Body Modification, Non-Therapeutic; Cosmetic Techniques; Therapeutics; Surgical Procedures, Operative; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Marc Goldstein, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2010
• First Posted: February 23, 2011
• Study Start: February 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: March 16, 2012

Record last verified: 2012-03

Locations

ZA (1); KE (1)