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This is a field case series of Unicirc under topical anaesthetic among adolescent boys, aged 12 to 15 years.
Boys are healthy, without severe anatomic abnormalities complicating circumcision. Boys with moderate phimosis and tight frenulum were included. Informed assent was obtained.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unicirc circumcision | Experimental | Unicirc circumcision under topical anaesthetic, wound sealing with cyanoacrylate tissue adhesive |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unicirc circumcision | Device | Unicirc circumcision under topical (EMLA) anaesthesia, wound sealing with cyanoacrylate tissue adhesive |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative Duration | Duration from placement of instrument to dressing | Intraoperative, 10-15 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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 of surgery, approximately 10-15 minutes |
| Healed at 4 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Norman Goldstuck | University of Stellenbosch | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Simunye Primary Healthcare | Cape Town | Western Cape | South Africa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25822727 | Background | Millard PS, Goldstuck ND. No-needle, single-visit adult male circumcision with Unicirc: a multi-centre field trial. PLoS One. 2015 Mar 30;10(3):e0121686. doi: 10.1371/journal.pone.0121686. eCollection 2015. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Unicirc Circumcision | Unicirc circumcision: Unicirc circumcision under topical (EMLA) anaesthesia, wound sealing with cyanoacrylate tissue adhesive |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Unicirc Circumcision | Unicirc circumcision: Unicirc circumcision under topical (EMLA) anaesthesia, wound sealing with cyanoacrylate 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 | Duration from placement of instrument to dressing | Posted | Median | Inter-Quartile Range | minutes | Intraoperative, 10-15 minutes |
|
|
1 month
We looked for intra-operative or post-operative bleeding, hematoma, infection, poor cosmetic result, wound dehiscence. None of these or other events occurred.
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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 | Unicirc Circumcision | Unicirc circumcision: Unicirc circumcision under topical (EMLA) anaesthesia, wound sealing with cyanoacrylate tissue adhesive |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding, hematoma, infection, wound dehiscence | Reproductive system and breast disorders | Systematic Assessment |
There were no limitations, other than the fact that this study was not a comparison study but a cohort interventional study. Followup was not totally complete but very nearly so.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter S. Millard, MD, Phd | University of New England | 2072992131 | 207 | pmillard@mac.com |
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Number of participants that are fully healed (epithelialized, no superficial ulcerations) at 4 weeks.
| At the 4-week followup visit |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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. | Posted | Median | Inter-Quartile Range | units on a scale (0 - 10) | Time of surgery, approximately 10-15 minutes |
|
|
|
| Secondary | Healed at 4 Weeks | Number of participants that are fully healed (epithelialized, no superficial ulcerations) at 4 weeks. | Posted | Count of Participants | Participants | At the 4-week followup visit |
|
|
|
| 0 |
| 54 |
| 0 |
| 54 |
| 0 |
| 54 |
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