NCT01688310

Brief Summary

This proposed randomized controlled trial will provide important data which will inform and enable the Mozambican government and global health programs to more effectively scale-up circumcision services. The investigators postulate that voluntary medical male circumcision using the Gomco clamp coupled with tissue adhesive meets WHO criteria for the ideal method: it is much easier to learn, faster, safer for both surgeons and patients, heals sooner, and is more cost effective than any other currently available technique.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

August 27, 2012

Completed
23 days until next milestone

First Posted

Study publicly available on registry

September 19, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
6 months until next milestone

Results Posted

Study results publicly available

September 10, 2013

Completed
Last Updated

September 10, 2013

Status Verified

June 1, 2013

Enrollment Period

7 months

First QC Date

August 27, 2012

Results QC Date

June 7, 2013

Last Update Submit

June 30, 2013

Conditions

Surgical Technique

Keywords

Gomco clamp instrumentTissue adhesiveOpen surgical circumcisionMinimally-invasive circumcision

Outcome Measures

Primary Outcomes (1)

  • Intraoperative Duration

    Time it takes for procedure from first manipulation of tissue under local anesthesia to dressing.

    1 year

Secondary Outcomes (6)

  • Difficulty in Learning and Performing Technique

    1 year

  • Time Required for Healing

    Within 6 weeks after surgery

  • Direct Costs

    Within 6 weeks after surgery

  • Pain Experienced

    2 days after surgery

  • Overall Patient Satisfaction

    Within 6 weeks after surgery

  • +1 more secondary outcomes

Other Outcomes (1)

  • Adverse Events

    1 yr

Study Arms (2)

Open surgical circumcision

ACTIVE COMPARATOR

Open surgical techniques, which are commonly used for circumcision in Mozambique, require good surgical skills and minor complications are common.

Procedure: Open surgical circumcision

Gomco clamp with tissue adhesive

EXPERIMENTAL

Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.

Procedure: Gomco Clamp with Tissue Adhesive

Interventions

Gomco Clamp with Tissue AdhesivePROCEDURE

According to WHO (2011), the Gomco clamp has "…an impeccable safety record. In the USA, where it is estimated that well over 1 million neonates are circumcised each year, the Gomco clamp has become the leading instrument used to perform non-ritual male circumcision." Tissue adhesive is widely used in multiple areas of medicine; specifically, multiple observational studies and RCTs have shown cyanoacrylate tissue adhesives to be superior to suture closure in VMMC.

Gomco clamp with tissue adhesive
Open surgical circumcisionPROCEDURE

The World Health Organization, in its Manual for Male Circumcision under Local Anaesthesia, describes three open surgical techniques (forceps assisted, dorsal slit and sleeve technique), all three of which involve (a) exposure of subcutaneous tissues and (b) suturing for hemostasis and for skin closure.

Open surgical circumcision

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy men \> 18 years of age requesting circumcision
  • No penile anatomical abnormalities or infections
  • Able to provide informed consent to participate
  • Willing to participate in follow-up visits

You may not qualify if:

  • Current illness
  • Penile abnormality or infection which contraindicates or would complicate circumcision
  • History of bleeding disorder
  • Past reaction to local anesthetic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro de Saúde São Lucas, UCM

Beira, Sofala, Mozambique

Location

Related Publications (16)

  • Gray RH, Kigozi G, Serwadda D, Makumbi F, Watya S, Nalugoda F, Kiwanuka N, Moulton LH, Chaudhary MA, Chen MZ, Sewankambo NK, Wabwire-Mangen F, Bacon MC, Williams CF, Opendi P, Reynolds SJ, Laeyendecker O, Quinn TC, Wawer MJ. Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial. Lancet. 2007 Feb 24;369(9562):657-66. doi: 10.1016/S0140-6736(07)60313-4.

    PMID: 17321311BACKGROUND

  • Bailey RC, Muga R, Poulussen R, Abicht H. The acceptability of male circumcision to reduce HIV infections in Nyanza Province, Kenya. AIDS Care. 2002 Feb;14(1):27-40. doi: 10.1080/09540120220097919.

    PMID: 11798403BACKGROUND

  • Lagarde E, Dirk T, Puren A, Reathe RT, Bertran A. Acceptability of male circumcision as a tool for preventing HIV infection in a highly infected community in South Africa. AIDS. 2003 Jan 3;17(1):89-95. doi: 10.1097/00002030-200301030-00012.

    PMID: 12478073BACKGROUND

  • Scott BE, Weiss HA, Viljoen JI. The acceptability of male circumcision as an HIV intervention among a rural Zulu population, Kwazulu-Natal, South Africa. AIDS Care. 2005 Apr;17(3):304-13. doi: 10.1080/09540120412331299744.

    PMID: 15832878BACKGROUND

  • Mattson CL, Bailey RC, Muga R, Poulussen R, Onyango T. Acceptability of male circumcision and predictors of circumcision preference among men and women in Nyanza Province, Kenya. AIDS Care. 2005 Feb;17(2):182-94. doi: 10.1080/09540120512331325671.

    PMID: 15763713BACKGROUND

  • Halperin DT, Fritz K, McFarland W, Woelk G. Acceptability of adult male circumcision for sexually transmitted disease and HIV prevention in Zimbabwe. Sex Transm Dis. 2005 Apr;32(4):238-9. doi: 10.1097/01.olq.0000149782.47456.5b. No abstract available.

    PMID: 15788922BACKGROUND

  • Bailey RC, Egesah O, Rosenberg S. Male circumcision for HIV prevention: a prospective study of complications in clinical and traditional settings in Bungoma, Kenya. Bull World Health Organ. 2008 Sep;86(9):669-77. doi: 10.2471/blt.08.051482.

    PMID: 18797642BACKGROUND

  • Kim HH, Goldstein M. High complication rates challenge the implementation of male circumcision for HIV prevention in Africa. Nat Clin Pract Urol. 2009 Feb;6(2):64-5. doi: 10.1038/ncpuro1279. Epub 2008 Dec 23.

    PMID: 19107114BACKGROUND

  • Lane V, Vajda P, Subramaniam R. Paediatric sutureless circumcision: a systematic literature review. Pediatr Surg Int. 2010 Feb;26(2):141-4. doi: 10.1007/s00383-009-2475-y. Epub 2009 Aug 26.

    PMID: 19707772BACKGROUND

  • Elmore JM, Smith EA, Kirsch AJ. Sutureless circumcision using 2-octyl cyanoacrylate (Dermabond): appraisal after 18-month experience. Urology. 2007 Oct;70(4):803-6. doi: 10.1016/j.urology.2007.07.002.

    PMID: 17991565BACKGROUND

  • Kaye JD, Kalisvaart JF, Cuda SP, Elmore JM, Cerwinka WH, Kirsch AJ. Sutureless and scalpel-free circumcision--more rapid, less expensive and better? J Urol. 2010 Oct;184(4 Suppl):1758-62. doi: 10.1016/j.juro.2010.03.081. Epub 2010 Aug 21.

    PMID: 20728122BACKGROUND

  • World Health Organization. Male circumcision: Global trends and determinants of prevalence, safety and acceptability, 2007

    BACKGROUND

  • World Health Organization. Manual for Male Circumcision under Local Anaesthesia. 2009.

    BACKGROUND

  • World Health Organization. Manual for early infant male circumcision under local anaesthesia. 2010.

    BACKGROUND

  • World Health Organization. Framework for Clinical Evaluation of Devices for Adult Male Circumcision. 2011.

    BACKGROUND

  • PEPFAR Next Generation Indicators Reference Guide, Vers 1.1, 2009 At www.pepfar.gov/documents/organization/81097.pdf

    BACKGROUND

MeSH Terms

Interventions

Tissue Adhesives

Intervention Hierarchy (Ancestors)

Biomedical and Dental MaterialsSpecialty Uses of ChemicalsChemical Actions and UsesSurgical Fixation DevicesSurgical EquipmentEquipment and SuppliesManufactured MaterialsTechnology, Industry, and Agriculture

Results Point of Contact

Title
Dr. Peter Millard
Organization
Catholic University of Mozambique Medical School
pmillard@mac.com
2078663503

Study Officials

  • Peter Millard, MD, PhD

    Universidade Catholic de Mozambique

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Director of the Health Center

Study Record Dates

First Submitted

August 27, 2012

First Posted

September 19, 2012

Study Start

August 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

September 10, 2013

Results First Posted

September 10, 2013

Record last verified: 2013-06

Locations

MO(1)