Clinical trial NCT01247844: Evaluation of Healing at Three Time Intervals and Potential for Spontaneous Detachment
Official title: Evaluation of Healing at Three Time Intervals and Potential for Spontaneous Detachment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Male Circumcision
Keywords: adult Males
circumcision
HIV prevention
device
Lead sponsor: FHI 360
Sponsor class: OTHER
Collaborators: name: Kenya National AIDS & STI Control Programme
name: Ministry of Medical Services, Kenya
name: EngenderHealth
name: Cornell University
First posted: 2010-11-24
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The objective of this research study is to evaluate the safety and acceptability of the Shang Ring method of medical male circumcision. The Shang Ring is a new circumcision device with a potential role in the safe and cost-effective delivery of circumcision services. The device, developed in China, consists of two concentric plastic rings. Following a ring penile block, the smaller ring is fitted at the base of the coronal sulcus. The foreskin is everted over the inner ring and the larger outer ring is secured over the inner ring. The foreskin is excised and several nicks are made on the incision line to prevent formation of a constricting, circumferential scab. No suturing is required.

In this study, the investigators will evaluate wound healing of men randomized to removal of the Shang Ring at one of three different points in time (Days 7, 14 or 21). Leaving the device on for 14 or 21 days constitutes extended wear of the device.

Sites: Homa Bay District Hospital, Nyanza Province, Kenya

Detailed description: The objective of this research study is to evaluate the safety and acceptability of the Shang Ring method of medical male circumcision. The Shang Ring is a new circumcision device with a potential role in the safe and cost-effective delivery of circumcision services. The device, developed in China, consists of two concentric plastic rings. Following a ring penile block, the smaller ring is fitted at the base of the coronal sulcus. The foreskin is everted over the inner ring and the larger outer ring is secured over the inner ring. The foreskin is excised and several nicks are made on the incision line to prevent formation of a constricting, circumferential scab. No suturing is required.

In this study, we will evaluate wound healing of men randomized to removal of the Shang Ring at one of three different points in time (Days 7, 14 or 21). Leaving the device on for 14 or 21 days constitutes extended wear of the device.

Although male circumcision has a demonstrated protective effect against HIV transmission, currently available surgical techniques and devices have limitations for widespread deployment in resource-poor areas. High costs and scarcity of trained providers hinder access to male circumcision services in resource-poor areas. Its simple design sets the Shang Ring apart from other male circumcision techniques. The Shang Ring has the potential for safe, effective and inexpensive delivery of male circumcision by trained healthcare personnel in HIV endemic countries.

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 mor than one week before the procedure;
* Must be free of genital ulcerations or other visible signs of sexually transmissible infections(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 an active genital infection, anatomic abnormality or other condition, which in the opinion of the surgeon, prevents the man from undergoing a circumcision;
* Has known bleeding/clotting disorder (e.g. hemophilia); and,
* Has thalassemia (an inherited autosomal recessive blood disease).

Primary outcomes:
measure: Asses healing time
timeFrame: six weeks
measure: spontaneous detachment of device
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Homa Bay
country: Kenya
facility: Homa Bay District Hospital
state: Nyanza
Study officials:
affiliation: Weill Cornell Medical College, NY, USA
name: Marc Goldstein, M.D.
role: STUDY_CHAIR
affiliation: EngenderHealth, NY, USA
name: Mark Barone, DVM; MS
role: STUDY_CHAIR
affiliation: Weill Medical College of Cornell University
name: Philip S. Li, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Weill Medical College of Cornell University
name: Puneet Masson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: EngenderHealth
name: Paul Perchal, MA
role: PRINCIPAL_INVESTIGATOR
affiliation: EngenderHealth
name: Jared Moguche, MB ChB
role: PRINCIPAL_INVESTIGATOR
affiliation: Engender Health
name: Quentin Awori, MB ChB
role: PRINCIPAL_INVESTIGATOR
affiliation: National AIDS/STD Control Programme, Nairobi, Kenya
name: Peter Cherutich, MB ChB MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: National AIDS/STD Control Programme
name: Nicholas Muraguri, MB ChB MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Ministry of Medical Services Nairobi Kenya
name: John Masasabi Wekesa, MB ChB MMed
role: PRINCIPAL_INVESTIGATOR
affiliation: Homa Bay District Hospital
name: Robert Otieno Simba, MMed
role: PRINCIPAL_INVESTIGATOR
References: