Circumcision, Male
Conditions
Brief summary
RCT of Unicirc under topical anesthetic w/ cyanoacrylate wound sealing vs. open surgical circumcision under local anesthetic with suturing.
Interventions
PROCEDUREUnicirc with tissue adhesive
As above
PROCEDUREOpen Surgical
As above
Sponsors
Simunye Primary Health Care
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male * Uncircumcised * With normal penile anatomy
Exclusion criteria
* Concurrent illness * History of bleeding disorder * Past reaction to local anesthetic * Infection * Penile abnormality which could complicate circumcision
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time Elapsed From First Clamp (Surgical) or Start of Insertion of Bell (Unicirc) to Beginning of Wound Dressing | Up to 30 minutes | Time elapsed from first clamp (surgical) or start of insertion of bell (Unicirc) to beginning of wound dressing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Pain 0=no Pain; 10=Worst Pain Ever | Up to 30 minutes | Self-described pain severity during procedure (scale 1 to 10). 0=no pain, 5=moderate pain, 10=worst pain ever |
| Completely Healed at 4 Weeks | At the 4-week followup visit | Number of participants who were completely healed at 4 weeks |
| Wound Dehiscence | Up to 4 weeks | Proportion experiencing wound dehiscence (\< 2 cm vs \> 2 cm) |
| Infection | Up to 4 weeks | Proportion experiencing post-op infection, determined clinically (treated with antibiotics) |
Countries
South Africa
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Unicirc With Tissue Adhesive Unicirc under topical anesthetic w/ cyanoacrylate wound sealing
Unicirc with tissue adhesive: As above | 50 |
| Open Surgical Open surgical circumcision under local anesthetic with suturing
Open Surgical: As above | 25 |
| Total | 75 |
Baseline characteristics
| Characteristic | Unicirc With Tissue Adhesive | Open Surgical | Total |
|---|---|---|---|
| Age, Customized Age 18-25 | 3 participants | 2 participants | 5 participants |
| Age, Customized Age 26-35 | 19 participants | 12 participants | 31 participants |
| Age, Customized Age 36+ | 28 participants | 11 participants | 39 participants |
| Region of Enrollment South Africa | 50 participants | 25 participants | 75 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 50 Participants | 25 Participants | 75 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 50 | 0 / 25 |
| serious Total, serious adverse events | 0 / 50 | 0 / 25 |
Outcome results
Primary
Time Elapsed From First Clamp (Surgical) or Start of Insertion of Bell (Unicirc) to Beginning of Wound Dressing
Time elapsed from first clamp (surgical) or start of insertion of bell (Unicirc) to beginning of wound dressing
Time frame: Up to 30 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Unicirc With Tissue Adhesive | Time Elapsed From First Clamp (Surgical) or Start of Insertion of Bell (Unicirc) to Beginning of Wound Dressing | 12 Minutes |
| Open Surgical | Time Elapsed From First Clamp (Surgical) or Start of Insertion of Bell (Unicirc) to Beginning of Wound Dressing | 25 Minutes |
Secondary
Completely Healed at 4 Weeks
Number of participants who were completely healed at 4 weeks
Time frame: At the 4-week followup visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Unicirc With Tissue Adhesive | Completely Healed at 4 Weeks | 39 participants |
| Open Surgical | Completely Healed at 4 Weeks | 16 participants |
Secondary
Infection
Proportion experiencing post-op infection, determined clinically (treated with antibiotics)
Time frame: Up to 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Unicirc With Tissue Adhesive | Infection | 0 participants |
| Open Surgical | Infection | 0 participants |
Secondary
Surgical Pain 0=no Pain; 10=Worst Pain Ever
Self-described pain severity during procedure (scale 1 to 10). 0=no pain, 5=moderate pain, 10=worst pain ever
Time frame: Up to 30 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unicirc With Tissue Adhesive | Surgical Pain 0=no Pain; 10=Worst Pain Ever | 1.7 units on a scale | Standard Deviation 1.3 |
| Open Surgical | Surgical Pain 0=no Pain; 10=Worst Pain Ever | 1.9 units on a scale | Standard Deviation 2.4 |
Secondary
Wound Dehiscence
Proportion experiencing wound dehiscence (\< 2 cm vs \> 2 cm)
Time frame: Up to 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Unicirc With Tissue Adhesive | Wound Dehiscence | Dehiscence < 2 cm longitudinally | 14 participants |
| Unicirc With Tissue Adhesive | Wound Dehiscence | Dehiscence > 2 cm longitudinally | 0 participants |
| Open Surgical | Wound Dehiscence | Dehiscence > 2 cm longitudinally | 0 participants |
| Open Surgical | Wound Dehiscence | Dehiscence < 2 cm longitudinally | 4 participants |