Comparison of the Shang Ring With Conventional Surgical Methods

NCT ID: NCT01300910

Last Updated: 2012-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2011-06-30

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).

Detailed 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.

Conditions

Circumcision, Male

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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.

Group Type: ACTIVE_COMPARATOR

Shang Ring

Intervention Type: 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

2

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.

Group Type: ACTIVE_COMPARATOR

Male circumcision

Intervention Type: 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.

Interventions

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

Intervention Type: DEVICE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 54 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

EngenderHealth

OTHER

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: collaborator

Kenya National AIDS & STI Control Programme

OTHER

Sponsor Role: collaborator

Ministry of Medical Services, Kenya

OTHER

Sponsor Role: collaborator

University Teaching Hospital, Lusaka, Zambia

OTHER

Sponsor Role: collaborator

FHI 360

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc Goldstein, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Homa Bay District Hospital male circumcision clinic

Homa Bay, Nyanza, Kenya

Society for Family Planning Clinic

Lusaka, , Zambia

Countries

Kenya; Zambia

References

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.

Reference Type: DERIVED

PMID: 33786810 (View on PubMed)

Other Identifiers

10220

Identifier Type: -

Identifier Source: org_study_id