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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unicirc with tissue adhesive | Experimental | Excision of foreskin with Unicirc device and sealing wound with tissue adhesive |
|
| Surgical control | Active Comparator | Surgical circumcision using forceps guided, dorsal slit, or sleeve method |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical Control | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative Duration | The number of minutes required to perform the surgical procedure | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | Bleeding, hematoma, infection and other rare adverse events | 1 month |
| Blood Loss | Number of ml of blood lost during the procedure, as assessed by the surgeon |
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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
-
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| Name | Affiliation | Role |
|---|---|---|
| Norman Goldstuck, MB ChB | Simunye Primary Health Care | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Simunye Primary Healthcare | Mitchells Plain | Western Cape | South Africa |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Surgical Control |
| 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 | The number of minutes required to perform the surgical procedure | Posted | Median | Inter-Quartile Range | Min | 1 hour |
|
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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 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post-op bleeding or hematoma | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter S. Millard, MD, PhD | 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 with tissue adhesive | Procedure | Excision of foreskin with Unicirc device and wound sealing with tissue adhesive |
|
| During procedure (up to 1 hour) |
| Number of Participants With Complete Epithelialization (Completely Healed) at 4 Weeks | The number of participants with complete epithelialization (completely healed) at 4 weeks | 1 month |
| Cosmetic Result | Regular: scar line straight without any irregularity Irregular: Some irregularity to scar line Scalloped: wavy appearane to scar line | 6 weeks |
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Number of Participants With Adverse Events | Bleeding, hematoma, infection and other rare adverse events | Posted | Number | participants | 1 month |
|
|
|
| Secondary | Blood Loss | Number of ml of blood lost during the procedure, as assessed by the surgeon | Posted | Median | Inter-Quartile Range | ml | During procedure (up to 1 hour) |
|
|
|
| Secondary | Number of Participants With Complete Epithelialization (Completely Healed) at 4 Weeks | The number of participants with complete epithelialization (completely healed) at 4 weeks | Posted | Number | participants | 1 month |
|
|
|
| Secondary | Cosmetic Result | Regular: scar line straight without any irregularity Irregular: Some irregularity to scar line Scalloped: wavy appearane to scar line | Posted | Number | participants | 6 weeks |
|
|
|
| 0 |
| 50 |
| 4 |
| 50 |
| EG001 | 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. | 0 | 50 | 9 | 50 |
| Post-op infection | Infections and infestations | Systematic Assessment |
|
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| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| Scalloped |
|