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To identify a 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.
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 randomized controlled trial compares the open surgical technique to an alternative minimally-invasive technique using a disposable Unicirc device with tissue adhesive. 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.
The study will randomly assign participants to one of two groups:
The participants will be evaluated during follow-up visits at 2 days, 7 days, 14 days, and 28 days after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open surgical circumcision | Active Comparator | The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common. |
|
| Unicirc device with tissue adhesive | Experimental | Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open surgical circumcision | Procedure | Open surgical circumcision using a technique approved by the WHO (dorsal slit) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative Duration | Amount of time from first manipulation of tissue under local anesthesia to dressing | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Difficulty in Learning and Performing Technique | Evaluated by doctor survey based on 5 point Likert scale
| 1 year |
| Number of Participants With Complete Wound Healing by Post-Surgery Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | Number of participants with intraoperative and post-operative adverse events, such as bleeding, hematoma, and infection | 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter S Millard, MD, PhD | Simunye Primary Health Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Simunye Primary Healthcare | Mitchells Plain | Western Cape | South Africa |
Healthy, uncircumcised men who were at least 18 years of age were eligible to participate in the study. All those who were enrolled and who showed up for their procedure were included in the study.
Recruitment occurred between 31 May, 2013 and 26 June, 2013. Participants were recruited via posters at two affiliated primary care clinics in Cape Town.
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| ID | Title | Description |
|---|---|---|
| FG000 | Open Surgical Circumcision | The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common. |
| FG001 | Unicirc Device With Tissue Adhesive | Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Open Surgical Circumcision | The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common. |
| BG001 | Unicirc Device With Tissue Adhesive |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Intraoperative Duration | Amount of time from first manipulation of tissue under local anesthesia to dressing | Posted | Median | Inter-Quartile Range | minutes | 1 hour |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Open Surgical Circumcision | The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild post-operative bleeding | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Peter Millard | University of New England | 2078663503 | pmillard@mac.com |
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| ID | Term |
|---|---|
| D014014 | Tissue Adhesives |
| ID | Term |
|---|---|
| D001697 | Biomedical and Dental Materials |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D053831 | Surgical Fixation Devices |
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| Unicirc device with tissue adhesive | Device | Removal of foreskin with Unicirc disposal device and wound sealing with tissue adhesive. |
|
| Within 4 weeks after surgery |
| Pain Experienced | Pain experienced during and after the procedure evaluated using a 10 point pain scale (0 signifies no pain and 10 signifies maximal pain | Within 2 days after surgery |
| Overall Patient Satisfaction | Patient satisfaction evaluated with questionnaire using satisfaction scale
| Within 6 weeks after surgery |
| Cosmetic Result | Cosmetic result evaluated by classification of scar line as regular (straight without any irregularity), irregular (not completely straight), or scalloped (with a wavy appearance) | Within 6 weeks after surgery |
Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Difficulty in Learning and Performing Technique | Evaluated by doctor survey based on 5 point Likert scale
| The four physicians that participated in this study performed both procedures (i.e. open surgical and Unicirc) on study participants. Three physicians had significant previous (non-study) experience performing open surgical circumcisions. All four had no to very limited previous experience performing Unicirc circumcisions. | Posted | Median | Full Range | units on Likert scale | 1 year |
|
|
|
| Secondary | Number of Participants With Complete Wound Healing by Post-Surgery Week 4 | Posted | Number | participants | Within 4 weeks after surgery |
|
|
|
| Secondary | Pain Experienced | Pain experienced during and after the procedure evaluated using a 10 point pain scale (0 signifies no pain and 10 signifies maximal pain | Posted | Mean | Standard Deviation | units on a 10-point pain scale | Within 2 days after surgery |
|
|
|
| Secondary | Overall Patient Satisfaction | Patient satisfaction evaluated with questionnaire using satisfaction scale
| Posted | Number | participants | Within 6 weeks after surgery |
|
|
|
| Secondary | Cosmetic Result | Cosmetic result evaluated by classification of scar line as regular (straight without any irregularity), irregular (not completely straight), or scalloped (with a wavy appearance) | Posted | Number | participants | Within 6 weeks after surgery |
|
|
|
| Other Pre-specified | Number of Participants With Adverse Events | Number of participants with intraoperative and post-operative adverse events, such as bleeding, hematoma, and infection | Posted | Number | participants | 1 year |
|
|
|
| 0 |
| 50 |
| 9 |
| 50 |
| EG001 | Unicirc Device With Tissue Adhesive | Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training. | 0 | 100 | 28 | 100 |
| Moderate post-operative bleeding | Surgical and medical procedures | Systematic Assessment | Required suturing to stop bleeding |
|
| Hematoma | Surgical and medical procedures | Systematic Assessment |
|
| Post-operative infection | Surgical and medical procedures | Systematic Assessment | Required antibiotic |
|
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| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| Not satisfied |
|
| Scalloped |
|
| Hematoma |
|
| Infection (antibiotic required) |
|