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

NCT01247844 | Completed

• 1 other identifier: 10214
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Male Circumcision

Keywords

adult Males; circumcision; HIV prevention; device

Outcome Measures

Primary Outcomes (2)

• Asses healing time

  Assess healing time from date of circumcision

  six weeks

• spontaneous detachment of device

  Spontaneous detachment from date of circumcision to three weeks post procedure

  21 days

Study Arms (3)

Day 7

OTHER

removal of Shang Ring at 7 days

Device: Shang Ring

Day 14

OTHER

removal of Shang Ring at 14 days

Device: Shang Ring

Day 21

OTHER

removal of Shang Ring at 21 days

Device: Shang Ring

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. 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

Day 14; Day 21; Day 7

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 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.

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 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).

Sponsors & Collaborators

• FHI 360: lead
• Kenya National AIDS & STI Control Programme: collaborator
• Ministry of Medical Services, Kenya: collaborator
• EngenderHealth: collaborator
• Cornell University: collaborator

Study Sites (1)

Homa Bay District Hospital

Homa Bay, Nyanza, 40300, Kenya

Location

Study Officials

• Marc Goldstein, M.D.

  Weill Cornell Medical College, NY, USA

  STUDY CHAIR

• Mark Barone, DVM; MS

  EngenderHealth, NY, USA

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2010
• First Posted: November 24, 2010
• Study Start: September 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: March 6, 2015

Record last verified: 2015-03

Locations

KE (1)