Male Circumcision
Conditions
Keywords
Circumcision, HIV prevention, Surgical device, Cyanoacrylate, Tissue Adhesive, voluntary
Brief summary
This is a field trial of the Unicirc instrument to excise the foreskin, plus use of cyanoacrylate tissue adhesive to seal the wound.
Interventions
PROCEDUREUnicirc instrument plus cyanoacrylate tissue adhesive
Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using 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
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Men at least 18 years of age
Exclusion criteria
* Poor general health * Anatomical abnormalities that would complicate circumcision * Bleeding disorder * Ongoing infection * Cannot attend followup visits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time for Procedure | 1 hour | Intraoperative time, total |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cosmetic Result Excellent | 4 weeks | Excellent: scar line straight without any irregularity Irregular: Some irregularity to scar line Scalloped: wavy appearane to scar line |
| Completely Healed at 4 Weeks | 4 weeks | Definition: Completely epithelialized; no superficial ulcerations or granulation tissue present |
| Wound Separation | 4 weeks | Wound separation caused by adhesive failure (minor --requires no treatment) |
| Participant Fully Satisfied and Would Recommend to Friends and Family | 4 weeks | Yes to both of the following questions: Are you fully satisfied with your circumcision result? Would you recommend circumcision to friends or family? |
Countries
South Africa
Participant flow
Recruitment details
Three generalist physicians (GPs) performed the circumcisions in individual consultation rooms in their own primary health care clinic. The study took place between January 20 and July 4, 2014.
Participants by arm
| Arm | Count |
|---|---|
| Unicirc With Tissue Adhesive Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate
Unicirc instrument plus cyanoacrylate tissue adhesive: Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive | 110 |
| Total | 110 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 6 |
Baseline characteristics
| Characteristic | Unicirc With Tissue Adhesive |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 110 Participants |
| Region of Enrollment South Africa | 110 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 110 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 110 |
| serious Total, serious adverse events | 0 / 110 |
Outcome results
Primary
Time for Procedure
Intraoperative time, total
Time frame: 1 hour
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Unicirc With Tissue Adhesive | Time for Procedure | 9.0 Min |
Secondary
Completely Healed at 4 Weeks
Definition: Completely epithelialized; no superficial ulcerations or granulation tissue present
Time frame: 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Unicirc With Tissue Adhesive | Completely Healed at 4 Weeks | 94 participants |
Secondary
Cosmetic Result Excellent
Excellent: scar line straight without any irregularity Irregular: Some irregularity to scar line Scalloped: wavy appearane to scar line
Time frame: 4 weeks
Population: 104 men came for their 4-week followup but the doctor(s) failed to note the cosmetic result in 2 men.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Unicirc With Tissue Adhesive | Cosmetic Result Excellent | 101 participants |
Secondary
Participant Fully Satisfied and Would Recommend to Friends and Family
Yes to both of the following questions: Are you fully satisfied with your circumcision result? Would you recommend circumcision to friends or family?
Time frame: 4 weeks
Population: 104 men came for their 4-week followup, but 1 man did not complete the satisfaction questions.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Unicirc With Tissue Adhesive | Participant Fully Satisfied and Would Recommend to Friends and Family | 103 participants |
Secondary
Wound Separation
Wound separation caused by adhesive failure (minor --requires no treatment)
Time frame: 4 weeks
Population: Wound dehiscence \< 2 cm. None required treatment. There were no participants with wound dehiscence \> 2 cm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Unicirc With Tissue Adhesive | Wound Separation | Separation > 2 cm longitudinally | 0 participants |
| Unicirc With Tissue Adhesive | Wound Separation | Separation < 2 cm longitudinally | 5 participants |