Clinical trial NCT01300910: Comparison of the Shang Ring With Conventional Surgical Methods
Official title: Comparison of the Shang Ring With Conventional Surgical Methods: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Circumcision, Male
Keywords: Adult Males
Circumcision
HIV prevention
Device
Shang Ring
Lead sponsor: FHI 360
Sponsor class: OTHER
Collaborators: name: EngenderHealth
name: Weill Medical College of Cornell University
name: Kenya National AIDS & STI Control Programme
name: Ministry of Medical Services, Kenya
name: University Teaching Hospital, Lusaka, Zambia
First posted: 2011-02-23
Enrollment: 400
Sex: MALE
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain scores on the Visual Analog Scale
timeFrame: Within the first 48 hours after circumcision
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: Up to six weeks after surgery
Secondary outcomes:
measure: Compare the cost of the Shang Ring procedure versus conventional surgery
timeFrame: Three months
Other outcomes:
Locations:
city: Homa Bay
country: Kenya
facility: Homa Bay District Hospital male circumcision clinic
state: Nyanza
city: Lusaka
country: Zambia
facility: Society for Family Planning Clinic
Study officials:
affiliation: Weill Medical College of Cornell University
name: Marc Goldstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.