Feasibility, Acceptability, and Safety of Neonatal Male Circumcision in Lusaka, Zambia

NCT01115335 | Completed Phase 4 DMC

• 1 other identifier: PS123541-06
• Study Type: interventional
• Target: 661
• Locations: 1 country
• Sites: 1

Brief Summary

In this study of neonatal male circumcision (NMC), the investigators will examine acceptability of among parents, feasibility of training providers and implementing services in various clinical settings, and the safety of service provision comparing three different surgical methods: the Gomco; the Plastibell; and the Mogen clamp. This operational study is being conducted to inform the scale up of neonatal male circumcision in Zambia.

Conditions

Neonatal Male Circumcision

Keywords

neonatal male circumcision; Gomco; Plastibell; Mogen; Safety; Uptake; Acceptability; Feasibility; Zambia

Outcome Measures

Primary Outcomes (1)

• Complication Rate

  Includes intra-operative and post-operative complications such as bleeding, infection, and cosmetic problems

  0-6 weeks after the circumcision procedure

Secondary Outcomes (3)

• Uptake of NMC

  Ongoing, over the course of the study (1.5 years)

• Provider Preferences

  Upon completion of training in NMC

• Parent Satisfaction

  6 weeks following the circumcision procedure

Study Arms (3)

Gomco

ACTIVE COMPARATOR

NMC performed using a Gomco clamp

Procedure: Neonatal male circumcision

Mogen clamp

ACTIVE COMPARATOR

NMC performed using a Mogen clamp

Procedure: Neonatal male circumcision

Plastibell

ACTIVE COMPARATOR

NMC performed using a Plastibell device

Procedure: Neonatal male circumcision

Interventions

Neonatal male circumcision PROCEDURE

Circumcision performed on a male infant within the first month of life, using one of 3 devices

Gomco; Mogen clamp; Plastibell

Eligibility Criteria

• Age: Up to 28 Days
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Male infants who are in the first day of life (including infants \< 24 hours old) and up to 4 weeks of age will be considered for circumcision
• Gestational age \>37 weeks at birth

You may not qualify if:

• Any current illness
• Bleeding diathesis or family history of bleeding disorder
• Abnormality of urethra or penile shaft such as hypospadias
• Local infection defined as redness, swelling, or a purulent discharge from the infant penis
• Greater than four weeks of age

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• University Teaching Hospital, Lusaka, Zambia: collaborator

Study Sites (1)

University Teaching Hospital and Matero Reference Clinic

Lusaka, Zambia

Location

Related Links

• Local NGO in Zambia overseeing study conduct

Study Officials

• Elizabeth M Stringer, MD

  University of Alabama at Birmingham and Centre for Infectious Disease Research of Zambia

  PRINCIPAL INVESTIGATOR

• Kasonde Bowa, MD

  University Teaching Hospital, Lusaka, Zambia

  PRINCIPAL INVESTIGATOR

• John Kachimba, MD

  University Teaching Hospital, Lusaka, Zambia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2010
• First Posted: May 4, 2010
• Study Start: October 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: January 1, 2012
• Last Updated: July 13, 2012

Record last verified: 2010-04

Locations

ZA (1)