Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a field trial of the Unicirc instrument to excise the foreskin, plus use of cyanoacrylate tissue adhesive to seal the wound.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unicirc with tissue adhesive | Experimental | Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unicirc instrument plus cyanoacrylate tissue adhesive | Procedure | Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive |
| Measure | Description | Time Frame |
|---|---|---|
| Time for Procedure | Intraoperative time, total | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Completely Healed at 4 Weeks | Definition: Completely epithelialized; no superficial ulcerations or granulation tissue present | 4 weeks |
| Wound Separation | Wound separation caused by adhesive failure (minor --requires no treatment) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Norman Goldstuck, MD | Department of Obstetrics and Gynaecology, Tygerberg Hospital, Cape Town, South Africa | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Simunye Primary Healthcare | Cape Town | Western Cape | South Africa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25822727 | Derived | 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. |
Not provided
Not provided
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Volunteers
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| 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 | Time for Procedure | Intraoperative time, total | Posted | Median | Inter-Quartile Range | Min | 1 hour |
|
|
Time period: 4 weeks
Active followup of volunteers at 1 and 4 weeks
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding requiring suture | Surgical and medical procedures | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter S. Millard, MD, PhD | University of New England | 2072992131 | pmillard@mac.com |
Not provided
| ID | Term |
|---|---|
| D003487 | Cyanoacrylates |
| ID | Term |
|---|---|
| D000179 | Acrylates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 4 weeks |
| Cosmetic Result Excellent | Excellent: scar line straight without any irregularity Irregular: Some irregularity to scar line Scalloped: wavy appearane to scar line | 4 weeks |
| 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? | 4 weeks |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Completely Healed at 4 Weeks | Definition: Completely epithelialized; no superficial ulcerations or granulation tissue present | Posted | Number | participants | 4 weeks |
|
|
|
| Secondary | Wound Separation | Wound separation caused by adhesive failure (minor --requires no treatment) | Wound dehiscence < 2 cm. None required treatment. There were no participants with wound dehiscence > 2 cm. | Posted | Number | participants | 4 weeks |
|
|
|
| Secondary | Cosmetic Result Excellent | Excellent: scar line straight without any irregularity Irregular: Some irregularity to scar line Scalloped: wavy appearane to scar line | 104 men came for their 4-week followup but the doctor(s) failed to note the cosmetic result in 2 men. | Posted | Number | participants | 4 weeks |
|
|
|
| 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? | 104 men came for their 4-week followup, but 1 man did not complete the satisfaction questions. | Posted | Number | participants | 4 weeks |
|
|
|
| 0 |
| 110 |
| 7 |
| 110 |
| Infection requiring antibiotics | Surgical and medical procedures | Systematic Assessment |
|
Not provided
Not provided
| D009570 |
| Nitriles |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D014014 | Tissue Adhesives |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |