Trial Outcomes & Findings for Unicirc Adolescent 12-15 Year Old Boys (NCT NCT02593630)

Results Overview

Duration from placement of instrument to dressing

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

54 participants

Primary outcome timeframe

Intraoperative, 10-15 minutes

Results posted on

2019-02-04

Participant Flow

Participant milestones

Participant milestones
Measure	Unicirc Circumcision Unicirc circumcision: Unicirc circumcision under topical (EMLA) anaesthesia, wound sealing with cyanoacrylate tissue adhesive
Overall Study STARTED	54
Overall Study COMPLETED	53
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Unicirc Adolescent 12-15 Year Old Boys

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Unicirc Circumcision n=54 Participants Unicirc circumcision: Unicirc circumcision under topical (EMLA) anaesthesia, wound sealing with cyanoacrylate tissue adhesive
Age, Categorical <=18 years	54 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	54 Participants n=5 Participants
Region of Enrollment South Africa	54 participants n=5 Participants

PRIMARY outcome

Timeframe: Intraoperative, 10-15 minutes

Duration from placement of instrument to dressing

Outcome measures

Outcome measures
Measure	Unicirc Circumcision n=54 Participants Unicirc circumcision: Unicirc circumcision under topical (EMLA) anaesthesia, wound sealing with cyanoacrylate tissue adhesive
Intraoperative Duration	9.5 minutes Interval 9.5 to 10.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Unicirc Circumcision n=54 Participants Unicirc circumcision: Unicirc circumcision under topical (EMLA) anaesthesia, wound sealing with cyanoacrylate tissue adhesive
Intraoperative Pain	1 units on a scale (0 - 10) Interval 0.5 to 1.5

SECONDARY outcome

Timeframe: At the 4-week followup visit

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

Outcome measures

Outcome measures
Measure	Unicirc Circumcision n=53 Participants Unicirc circumcision: Unicirc circumcision under topical (EMLA) anaesthesia, wound sealing with cyanoacrylate tissue adhesive
Healed at 4 Weeks	53 Participants

Adverse Events

Unicirc Circumcision

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Unicirc Circumcision n=54 participants at risk Unicirc circumcision: Unicirc circumcision under topical (EMLA) anaesthesia, wound sealing with cyanoacrylate tissue adhesive
Reproductive system and breast disorders Bleeding, hematoma, infection, wound dehiscence	0.00% 0/54 • 1 month We looked for intra-operative or post-operative bleeding, hematoma, infection, poor cosmetic result, wound dehiscence. None of these or other events occurred.

Additional Information

Peter S. Millard, MD, Phd

University of New England

Phone: 2072992131

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place