Circumcision, Male
Conditions
Brief summary
This is a field case series of Unicirc under topical anaesthetic among adolescent boys, aged 12 to 15 years.
Detailed description
Boys are healthy, without severe anatomic abnormalities complicating circumcision. Boys with moderate phimosis and tight frenulum were included. Informed assent was obtained.
Interventions
DEVICEUnicirc circumcision
Unicirc circumcision under topical (EMLA) anaesthesia, wound sealing with cyanoacrylate tissue adhesive
Sponsors
Simunye Primary Health Care
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
12 Years to 15 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative Duration | Intraoperative, 10-15 minutes | Duration from placement of instrument to dressing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Healed at 4 Weeks | At the 4-week followup visit | Number of participants that are fully healed (epithelialized, no superficial ulcerations) at 4 weeks. |
Countries
South Africa
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Unicirc Circumcision Unicirc circumcision: Unicirc circumcision under topical (EMLA) anaesthesia, wound sealing with cyanoacrylate tissue adhesive | 54 |
| Total | 54 |
Baseline characteristics
| Characteristic | Unicirc Circumcision |
|---|---|
| Age, Categorical <=18 years | 54 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Region of Enrollment South Africa | 54 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 54 |
| other Total, other adverse events | 0 / 54 |
| serious Total, serious adverse events | 0 / 54 |
Outcome results
Primary
Intraoperative Duration
Duration from placement of instrument to dressing
Time frame: Intraoperative, 10-15 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Unicirc Circumcision | Intraoperative Duration | 9.5 minutes |
Secondary
Healed at 4 Weeks
Number of participants that are fully healed (epithelialized, no superficial ulcerations) at 4 weeks.
Time frame: At the 4-week followup visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Unicirc Circumcision | Healed at 4 Weeks | 53 Participants |
Secondary
Intraoperative Pain
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Unicirc Circumcision | Intraoperative Pain | 1 units on a scale (0 - 10) |