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RCT of Unicirc under topical anesthetic w/ cyanoacrylate wound sealing vs. open surgical circumcision under local anesthetic with suturing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unicirc with tissue adhesive | Experimental | Unicirc under topical anesthetic w/ cyanoacrylate wound sealing |
|
| Open Surgical | Active Comparator | Open surgical circumcision under local anesthetic with suturing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unicirc with tissue adhesive | Procedure | As above |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time Elapsed From First Clamp (Surgical) or Start of Insertion of Bell (Unicirc) to Beginning of Wound Dressing | Time elapsed from first clamp (surgical) or start of insertion of bell (Unicirc) to beginning of wound dressing | Up to 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical Pain 0=no Pain; 10=Worst Pain Ever | Self-described pain severity during procedure (scale 1 to 10). 0=no pain, 5=moderate pain, 10=worst pain ever | Up to 30 minutes |
| Completely Healed at 4 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lonmin Hospital | Marikana | Northwest | 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. | |
| 27299735 | Derived | Shenje J, Millard PS. Sutureless Adult Voluntary Male Circumcision with Topical Anesthetic: A Randomized Field Trial of Unicirc, a Single-Use Surgical Instrument. PLoS One. 2016 Jun 14;11(6):e0157065. doi: 10.1371/journal.pone.0157065. eCollection 2016. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Unicirc With Tissue Adhesive | Unicirc under topical anesthetic w/ cyanoacrylate wound sealing Unicirc with tissue adhesive: As above |
| FG001 | Open Surgical | Open surgical circumcision under local anesthetic with suturing Open Surgical: As above |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Unicirc With Tissue Adhesive | Unicirc under topical anesthetic w/ cyanoacrylate wound sealing Unicirc with tissue adhesive: As above |
| BG001 | Open Surgical | Open surgical circumcision under local anesthetic with suturing Open Surgical: As above |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 Elapsed From First Clamp (Surgical) or Start of Insertion of Bell (Unicirc) to Beginning of Wound Dressing | Time elapsed from first clamp (surgical) or start of insertion of bell (Unicirc) to beginning of wound dressing | Posted | Median | Inter-Quartile Range | Minutes | Up to 30 minutes |
|
Any any time during study (4-6 weeks)
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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 With Tissue Adhesive | Unicirc under topical anesthetic w/ cyanoacrylate wound sealing Unicirc with tissue adhesive: As above |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post-op bleeding | Surgical and medical procedures | Systematic Assessment | Bleeding requiring sutures |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Justin Shenje | U of Cape Town | 0027788938497 | justintshenje@gmail.com |
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| ID | Term |
|---|---|
| D014014 | Tissue Adhesives |
| D061887 | Conversion to Open Surgery |
| 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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| Open Surgical |
| Procedure |
As above |
|
Number of participants who were completely healed at 4 weeks
| At the 4-week followup visit |
| Wound Dehiscence | Proportion experiencing wound dehiscence (< 2 cm vs > 2 cm) | Up to 4 weeks |
| Infection | Proportion experiencing post-op infection, determined clinically (treated with antibiotics) | Up to 4 weeks |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Surgical Pain 0=no Pain; 10=Worst Pain Ever | Self-described pain severity during procedure (scale 1 to 10). 0=no pain, 5=moderate pain, 10=worst pain ever | Posted | Mean | Standard Deviation | units on a scale | Up to 30 minutes |
|
|
|
| Secondary | Completely Healed at 4 Weeks | Number of participants who were completely healed at 4 weeks | Posted | Number | participants | At the 4-week followup visit |
|
|
|
| Secondary | Wound Dehiscence | Proportion experiencing wound dehiscence (< 2 cm vs > 2 cm) | Posted | Number | participants | Up to 4 weeks |
|
|
|
| Secondary | Infection | Proportion experiencing post-op infection, determined clinically (treated with antibiotics) | Posted | Number | participants | Up to 4 weeks |
|
|
|
| 0 |
| 50 |
| 3 |
| 50 |
| EG001 | Open Surgical | Open surgical circumcision under local anesthetic with suturing Open Surgical: As above | 0 | 25 | 0 | 25 |
|
| Intraoperative bleeding requiring sutures | Surgical and medical procedures | Systematic Assessment |
|
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| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D004724 | Endoscopy |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |