An interventional study of Unicirc instrument plus cyanoacrylate tissue adhesive in Male Circumcision, sponsored by Simunye Primary Health Care. Completed at 1 site in South Africa. Open to male participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-06.
Sponsored by Simunye Primary Health Care · Not applicable, Interventional, and Prevention
This is a field trial of the Unicirc instrument to excise the foreskin, plus use of cyanoacrylate tissue adhesive to seal the wound.
Simunye Primary Health Care is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate
Procedure: 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
Also known as: Unicirc, Cyanoacrylate
Time for Procedure
Intraoperative time, total
Time frame: 1 hour
Completely Healed at 4 Weeks
Definition: Completely epithelialized; no superficial ulcerations or granulation tissue present
Time frame: 4 weeks
Wound Separation
Wound separation caused by adhesive failure (minor --requires no treatment)
Time frame: 4 weeks
Cosmetic Result Excellent
Excellent: scar line straight without any irregularity Irregular: Some irregularity to scar line Scalloped: wavy appearane to scar line
Time frame: 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?
Time frame: 4 weeks
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.
| Milestone | Unicirc With Tissue Adhesive |
|---|---|
| Started | 110 |
| 1 week followup | 110 |
| 4 week followup | 104 |
| Completed | 104 |
| Not completed | 6 |
| Withdrew: Lost to follow-up | 6 |
Intraoperative time, total
| Min | Unicirc With Tissue Adhesive |
|---|---|
| Time for Procedure | 9.0 (9.0 to 10.0) |
Definition: Completely epithelialized; no superficial ulcerations or granulation tissue present
| participants | Unicirc With Tissue Adhesive |
|---|---|
| Completely Healed at 4 Weeks | 94 |
Wound separation caused by adhesive failure (minor --requires no treatment)
| participants | Unicirc With Tissue Adhesive |
|---|---|
| Separation > 2 cm longitudinally | 0 |
| Separation < 2 cm longitudinally | 5 |
Excellent: scar line straight without any irregularity Irregular: Some irregularity to scar line Scalloped: wavy appearane to scar line
| participants | Unicirc With Tissue Adhesive |
|---|---|
| Cosmetic Result Excellent | 101 |
Yes to both of the following questions: Are you fully satisfied with your circumcision result? Would you recommend circumcision to friends or family?
| participants | Unicirc With Tissue Adhesive |
|---|---|
| Participant Fully Satisfied and Would Recommend to Friends and Family | 103 |
Collected over Time period: 4 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Unicirc With Tissue Adhesive | — | 0/110 (0%) | 7/110 (6.4%) |
| Event | Unicirc With Tissue Adhesive |
|---|---|
| Bleeding requiring sutureSurgical and medical procedures | 5/110 |
| Infection requiring antibioticsSurgical and medical procedures | 2/110 |
Volunteers
| Age, Categorical(Participants) | Unicirc With Tissue Adhesive |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 110 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Unicirc With Tissue Adhesive |
|---|---|
| Female | 0 |
| Male | 110 |
| Region of Enrollment(participants) | Unicirc With Tissue Adhesive |
|---|---|
| South Africa | 110 |
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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Simunye Primary Health Care