Evaluation of Healing at Three Time Intervals and Potential for Spontaneous Detachment

This study has been completed.
Sponsor:
Collaborators:
Kenya National AIDS & STI Control Programme
Ministry of Medical Services, Kenya
EngenderHealth
Cornell University
Information provided by:
FHI 360
ClinicalTrials.gov Identifier:
NCT01247844
First received: September 7, 2010
Last updated: February 18, 2011
Last verified: February 2011
  Purpose

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


Condition Intervention
Male Circumcision
Device: Shang Ring

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Healing at Three Time Intervals and Potential for Spontaneous Detachment

Further study details as provided by FHI 360:

Primary Outcome Measures:
  • Moderate and severe adverse events [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    Removal of Shang Ring after curcumcision at 7 days

  • Moderate and severe adverse events [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    Shang Ring removal after circumcision at 14 days

  • Moderate and severe adverse events [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
    Shang Ring removal after ciscumcision at 21 days


Enrollment: 50
Study Start Date: September 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
removal of Shang Ring at 7 days
Device: 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. The man must return to the clinic for device removal. To remove the device, the outer ring locking mechanism is 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
No Intervention: 2
removal of Shang Ring at 14 days
Device: 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. The man must return to the clinic for device removal. To remove the device, the outer ring locking mechanism is 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
No Intervention: 3
removal of Shang Ring at 21 days
Device: 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. The man must return to the clinic for device removal. To remove the device, the outer ring locking mechanism is 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

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

Ages Eligible for Study:   18 Years to 54 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01247844

Locations
Kenya
Homa Bay District Hospital
Homa Bay, Nyanza, Kenya, 40300
Sponsors and Collaborators
FHI 360
Kenya National AIDS & STI Control Programme
Ministry of Medical Services, Kenya
EngenderHealth
Cornell University
Investigators
Study Chair: Marc Goldstein, M.D. Weill Cornell Medical College, NY, USA
Study Chair: Mark Barone, DVM; MS EngenderHealth, NY, USA
Principal Investigator: Philip S. Li, MD Weill Medical College of Cornell University
Principal Investigator: Puneet Masson, MD Weill Medical College of Cornell University
Principal Investigator: Paul Perchal, MA EngenderHealth
Principal Investigator: Jared Moguche, MB ChB EngenderHealth
Principal Investigator: Quentin Awori, MB ChB Engender Health
Principal Investigator: Peter Cherutich, MB ChB MPH National AIDS/STD Control Programme, Nairobi, Kenya
Principal Investigator: Nicholas Muraguri, MB ChB MPH National AIDS/STD Control Programme
Principal Investigator: John Masasabi Wekesa, MB ChB MMed Ministry of Medical Services Nairobi Kenya
Principal Investigator: Robert Otieno Simba, MMed Homa Bay District Hospital
  More Information

No publications provided

Responsible Party: David Sokal, M.D, FHI
ClinicalTrials.gov Identifier: NCT01247844     History of Changes
Other Study ID Numbers: 10214
Study First Received: September 7, 2010
Last Updated: February 18, 2011
Health Authority: United States: Institutional Review Board
Kenya: National Institutional Review Board

Keywords provided by FHI 360:
adult Males
circumcision
HIV prevention
device

ClinicalTrials.gov processed this record on September 18, 2014