Unicirc Adolescent 12-15 Year Old Boys

• Sponsor: Simunye Primary Health Care (Other)
• Overall Status: Completed
• CT.gov ID: NCT02593630
• Collaborator: (none)
• Enrollment: 54
• Location: 1
• Arm: 1
• Actual Duration (Months): 7.5
• Patients Per Site Per Month: 7.2

Study Details

Study Description

Brief Summary

This is a field case series of Unicirc under topical anaesthetic among adolescent boys, aged 12 to 15 years.

Condition or Disease	Intervention/Treatment	Phase
Circumcision, Male	Device: Unicirc circumcision	Phase 4

Detailed Description

Boys are healthy, without severe anatomic abnormalities complicating circumcision. Boys with moderate phimosis and tight frenulum were included. Informed assent was obtained.

Study Design

• Study Type: Interventional
• Actual Enrollment: 54 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Field Study of Unicirc Circumcision in Adolescent Boys, Aged 12 to 15 Years.
• Actual Study Start Date: Apr 1, 2016
• Actual Primary Completion Date: Nov 15, 2016
• Actual Study Completion Date: Nov 15, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Unicirc circumcision Unicirc circumcision under topical anaesthetic, wound sealing with cyanoacrylate tissue adhesive	Device: Unicirc circumcision; Unicirc circumcision under topical (EMLA) anaesthesia, wound sealing with cyanoacrylate tissue adhesive

Outcome Measures

Primary Outcome Measures

1. Intraoperative Duration [Intraoperative, 10-15 minutes]

   Duration from placement of instrument to dressing

Secondary Outcome Measures

1. Intraoperative Pain [Time of surgery, approximately 10-15 minutes]

   Intraoperative pain, measured on a standard 10 point pain scale (0=no pain, 5=moderate pain, 10 severe pain) using a pain face diagram.

2. Healed at 4 Weeks [At the 4-week followup visit]

   Number of participants that are fully healed (epithelialized, no superficial ulcerations) at 4 weeks.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 15 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• healthy boys desiring circumcision

Exclusion Criteria:

• current illness

• bleeding disorder

• reaction to local anaesthetic

• infection

• any penile abnormality potentially complicating circumcision

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Simunye Primary Healthcare	Cape Town	Western Cape	South Africa

Sponsors and Collaborators

• Simunye Primary Health Care

Investigators

• Study Director: Norman Goldstuck, University of Stellenbosch

Study Documents (Full-Text)

None provided.

More Information

Publications

• Millard PS, Goldstuck ND. No-needle, single-visit adult male circumcision with Unicirc: a multi-centre field trial. PLoS One. 2015 Mar 30;10(3):e0121686. doi: 10.1371/journal.pone.0121686. eCollection 2015.

• Responsible Party: Peter Millard, PI, University of New England
• ClinicalTrials.gov Identifier: NCT02593630
• Other Study ID Numbers: Unicirc Adolescent
• First Posted: Nov 1, 2015
• Last Update Posted: Feb 4, 2019
• Last Verified: Jan 1, 2019

Study Results

Participant Flow

Arm/Group Title	Unicirc Circumcision
Arm/Group Description	Unicirc circumcision: Unicirc circumcision under topical (EMLA) anaesthesia, wound sealing with cyanoacrylate tissue adhesive
Period Title: Overall Study
STARTED	54
COMPLETED	53
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Unicirc Circumcision
Arm/Group Description	Unicirc circumcision: Unicirc circumcision under topical (EMLA) anaesthesia, wound sealing with cyanoacrylate tissue adhesive
Overall Participants	54
Age (Count of Participants)
<=18 years	54 100%
Between 18 and 65 years	0 0%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	54 100%
Region of Enrollment (participants) [Number]
South Africa	54 100%

Outcome Measures

1. Primary Outcome

Title	Intraoperative Duration
Description	Duration from placement of instrument to dressing
Time Frame	Intraoperative, 10-15 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Unicirc Circumcision
Arm/Group Description	Unicirc circumcision: Unicirc circumcision under topical (EMLA) anaesthesia, wound sealing with cyanoacrylate tissue adhesive
Measure Participants	54
Median (Inter-Quartile Range) [minutes]	9.5

2. Secondary Outcome

Title	Intraoperative Pain
Description	Intraoperative pain, measured on a standard 10 point pain scale (0=no pain, 5=moderate pain, 10 severe pain) using a pain face diagram.
Time Frame	Time of surgery, approximately 10-15 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Unicirc Circumcision
Arm/Group Description	Unicirc circumcision under topical anaesthetic, wound sealing with cyanoacrylate tissue adhesive Unicirc circumcision: Unicirc circumcision under topical (EMLA) anaesthesia, wound sealing with cyanoacrylate tissue adhesive
Measure Participants	54
Median (Inter-Quartile Range) [units on a scale (0 - 10)]	1

3. Secondary Outcome

Title	Healed at 4 Weeks
Description	Number of participants that are fully healed (epithelialized, no superficial ulcerations) at 4 weeks.
Time Frame	At the 4-week followup visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Unicirc Circumcision
Arm/Group Description	Unicirc circumcision: Unicirc circumcision under topical (EMLA) anaesthesia, wound sealing with cyanoacrylate tissue adhesive
Measure Participants	53
Count of Participants [Participants]	53 98.1%

Adverse Events

Time Frame	1 month
Adverse Event Reporting Description	We looked for intra-operative or post-operative bleeding, hematoma, infection, poor cosmetic result, wound dehiscence. None of these or other events occurred.
Arm/Group Title	Unicirc Circumcision
Arm/Group Description	Unicirc circumcision: Unicirc circumcision under topical (EMLA) anaesthesia, wound sealing with cyanoacrylate tissue adhesive
All Cause Mortality
	Unicirc Circumcision
	Affected / at Risk (%)	# Events
Total	0/54 (0%)
Serious Adverse Events
	Unicirc Circumcision
	Affected / at Risk (%)	# Events
Total	0/54 (0%)
Other (Not Including Serious) Adverse Events
	Unicirc Circumcision
	Affected / at Risk (%)	# Events
Total	0/54 (0%)
Reproductive system and breast disorders
Bleeding, hematoma, infection, wound dehiscence	0/54 (0%)	0

Limitations/Caveats

There were no limitations, other than the fact that this study was not a comparison study but a cohort interventional study. Followup was not totally complete but very nearly so.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.