Circumcision
Conditions
Keywords
Circumcision, Voluntary medical male circumcision, Minimally-invasive, HIV prevention
Brief summary
This study will evaluate a new, minimally-invasive surgical circumcision technique for men, which is easy to learn and perform, is safe, and is associated with high patient satisfaction and excellent cosmetic results.
Detailed description
Voluntary medical male circumcision (VMMC) is a priority preventive intervention for HIV transmission. Currently, the most widely used VMMC technique in South Africa is open surgical circumcision. According to the Framework for Clinical Evaluation of Devices for Adult Male Circumcision (WHO, 2011): WHO and other health authorities wish to identify one or more devices that (a) would make the VMMC safer, easier, and quicker; (b) would have more rapid healing than current methods and/or might entail less risk of HIV transmission in the post-operative period; (c) could be performed safely by health-care providers with a minimal level of training; and (d) would be cost-effective compared to standard surgical methods for male circumcision scale up. This quasi-experimental compares the open surgical technique to an alternative minimally-invasive technique using the disposable Unicirc device with tissue adhesive. The controls come from a separate randomized controlled trial (Unicirc 001) that was conducted just prior to the Unicirc 002 case series of 50 subjects. The investigators postulate that VMMC using the Unicirc device meets WHO criteria for the ideal method to scale up: it is an easier technique to learn and perform, requires less intraoperative time, is safer for both surgeons and patients, heals quicker, and is more cost effective than other currently available techniques. The disposable nature of the device is an immense advantage as it eliminates the need to sterilize and can therefore be used in resource-limited settings. It also reduces the chances of infection caused by contaminated instruments.
Interventions
PROCEDURESurgical Control
The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions.
PROCEDUREUnicirc with tissue adhesive
Excision of foreskin with Unicirc device and wound sealing with tissue adhesive
Sponsors
Simunye Primary Health Care
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy men at least 18 years of age requesting circumcision No anatomical penile abnormalities or infections Able to provide informed consent to participate Willing to participate in follow-up visits -
Exclusion criteria
Current illness Penile abnormality or infection which contraindicates or would complicate circumcision History of bleeding disorder Past reaction to local anesthetic \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative Duration | 1 hour | The number of minutes required to perform the surgical procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | 1 month | Bleeding, hematoma, infection and other rare adverse events |
| Blood Loss | During procedure (up to 1 hour) | Number of ml of blood lost during the procedure, as assessed by the surgeon |
| Number of Participants With Complete Epithelialization (Completely Healed) at 4 Weeks | 1 month | The number of participants with complete epithelialization (completely healed) at 4 weeks |
| Cosmetic Result | 6 weeks | Regular: scar line straight without any irregularity Irregular: Some irregularity to scar line Scalloped: wavy appearane to scar line |
Countries
South Africa
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Unicirc With Tissue Adhesive Excision of foreskin with Unicirc device and sealing wound with tissue adhesive
Unicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive | 50 |
| Surgical Control Surgical circumcision using forceps guided, dorsal slit, or sleeve method
Surgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions. | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Unicirc With Tissue Adhesive | Surgical Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants | 50 Participants | 100 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 50 Participants | 50 Participants | 100 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 50 | 9 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Intraoperative Duration
The number of minutes required to perform the surgical procedure
Time frame: 1 hour
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Unicirc With Tissue Adhesive | Intraoperative Duration | 9.0 Min |
| Surgical Control | Intraoperative Duration | 22.6 Min |
Secondary
Blood Loss
Number of ml of blood lost during the procedure, as assessed by the surgeon
Time frame: During procedure (up to 1 hour)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Unicirc With Tissue Adhesive | Blood Loss | 1.5 ml |
| Surgical Control | Blood Loss | 5.5 ml |
Secondary
Cosmetic Result
Regular: scar line straight without any irregularity Irregular: Some irregularity to scar line Scalloped: wavy appearane to scar line
Time frame: 6 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Unicirc With Tissue Adhesive | Cosmetic Result | Regular | 50 participants |
| Unicirc With Tissue Adhesive | Cosmetic Result | Irregular | 0 participants |
| Unicirc With Tissue Adhesive | Cosmetic Result | Scalloped | 0 participants |
| Surgical Control | Cosmetic Result | Regular | 20 participants |
| Surgical Control | Cosmetic Result | Irregular | 8 participants |
| Surgical Control | Cosmetic Result | Scalloped | 22 participants |
Secondary
Number of Participants With Adverse Events
Bleeding, hematoma, infection and other rare adverse events
Time frame: 1 month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Unicirc With Tissue Adhesive | Number of Participants With Adverse Events | 4 participants |
| Surgical Control | Number of Participants With Adverse Events | 9 participants |
Secondary
Number of Participants With Complete Epithelialization (Completely Healed) at 4 Weeks
The number of participants with complete epithelialization (completely healed) at 4 weeks
Time frame: 1 month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Unicirc With Tissue Adhesive | Number of Participants With Complete Epithelialization (Completely Healed) at 4 Weeks | 49 participants |
| Surgical Control | Number of Participants With Complete Epithelialization (Completely Healed) at 4 Weeks | 49 participants |