A Phase 4 interventional study of Unicirc with tissue adhesive and Open Surgical in Circumcision, Male, sponsored by Simunye Primary Health Care. Completed at 1 site in South Africa. Open to male participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-03.
Sponsored by Simunye Primary Health Care · Phase 4, Interventional, and Prevention
RCT of Unicirc under topical anesthetic w/ cyanoacrylate wound sealing vs. open surgical circumcision under local anesthetic with suturing.
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:
Unicirc under topical anesthetic w/ cyanoacrylate wound sealing
Procedure: Unicirc with tissue adhesive
Open surgical circumcision under local anesthetic with suturing
Procedure: Open Surgical
As above
As above
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
Time frame: Up to 30 minutes
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
Time frame: Up to 30 minutes
Completely Healed at 4 Weeks
Number of participants who were completely healed at 4 weeks
Time frame: At the 4-week followup visit
Wound Dehiscence
Proportion experiencing wound dehiscence (\< 2 cm vs \> 2 cm)
Time frame: Up to 4 weeks
Infection
Proportion experiencing post-op infection, determined clinically (treated with antibiotics)
Time frame: Up to 4 weeks
| Milestone | Unicirc With Tissue Adhesive | Open Surgical |
|---|---|---|
| Started | 50 | 25 |
| Completed | 43 | 23 |
| Not completed | 7 | 2 |
Time elapsed from first clamp (surgical) or start of insertion of bell (Unicirc) to beginning of wound dressing
| Minutes | Unicirc With Tissue Adhesive | Open Surgical |
|---|---|---|
| Time Elapsed From First Clamp (Surgical) or Start of Insertion of Bell (Unicirc) to Beginning of Wound Dressing | 12 (11 to 17) | 25 (21 to 35) |
Self-described pain severity during procedure (scale 1 to 10). 0=no pain, 5=moderate pain, 10=worst pain ever
| units on a scale | Unicirc With Tissue Adhesive | Open Surgical |
|---|---|---|
| Surgical Pain 0=no Pain; 10=Worst Pain Ever | 1.7 ± 1.3 | 1.9 ± 2.4 |
Number of participants who were completely healed at 4 weeks
| participants | Unicirc With Tissue Adhesive | Open Surgical |
|---|---|---|
| Completely Healed at 4 Weeks | 39 | 16 |
Proportion experiencing wound dehiscence (\< 2 cm vs \> 2 cm)
| participants | Unicirc With Tissue Adhesive | Open Surgical |
|---|---|---|
| Dehiscence > 2 cm longitudinally | 0 | 0 |
| Dehiscence < 2 cm longitudinally | 14 | 4 |
Proportion experiencing post-op infection, determined clinically (treated with antibiotics)
| participants | Unicirc With Tissue Adhesive | Open Surgical |
|---|---|---|
| Infection | 0 | 0 |
Collected over Any any time during study (4-6 weeks). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Unicirc With Tissue Adhesive | — | 0/50 (0%) | 3/50 (6%) |
| Open Surgical | — | 0/25 (0%) | 0/25 (0%) |
| Event | Unicirc With Tissue Adhesive | Open Surgical |
|---|---|---|
| Intraoperative bleeding requiring suturesSurgical and medical procedures | 2/50 | 0/25 |
| Post-op bleedingSurgical and medical procedures | 1/50 | 0/25 |
| Age, Customized(participants) | Unicirc With Tissue Adhesive | Open Surgical | Total |
|---|---|---|---|
| Age 18-25 | 3 | 2 | 5 |
| Age 26-35 | 19 | 12 | 31 |
| Age 36+ | 28 | 11 | 39 |
| Sex: Female, Male(Participants) | Unicirc With Tissue Adhesive | Open Surgical | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 50 | 25 | 75 |
| Region of Enrollment(participants) | Unicirc With Tissue Adhesive | Open Surgical | Total |
|---|---|---|---|
| South Africa | 50 | 25 | 75 |
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