Phase 4
N=75
Unicirc vs Open Surgical Circumcision
Circumcision, Male
Bottom Line
View on ClinicalTrials.gov: NCT02443792 ↗Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcome: Primary: Time Elapsed From First Clamp (Surgical) or Start of Insertion of Bell (Unicirc) to Beginning of Wound Dressing — 12; 25 Minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Unicirc with tissue adhesive (Procedure); Open Surgical (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Simunye Primary Health Care
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time Elapsed From First Clamp (Surgical) or Start of Insertion of Bell (Unicirc) to Beginning of Wound Dressing |
12; 25 | — |
| SECONDARY Surgical Pain 0=no Pain; 10=Worst Pain Ever |
1.7; 1.9 | — |
| SECONDARY Completely Healed at 4 Weeks |
39; 16 | — |
| SECONDARY Wound Dehiscence |
0; 0; 14; 4 | — |
| SECONDARY Infection |
0; 0 | — |
Summary
RCT of Unicirc under topical anesthetic w/ cyanoacrylate wound sealing vs. open surgical circumcision under local anesthetic with suturing.
Eligibility Criteria
Inclusion Criteria
- Healthy male
- Uncircumcised
- With normal penile anatomy
Exclusion Criteria
- Concurrent illness
- History of bleeding disorder
- Past reaction to local anesthetic
- Infection
- Penile abnormality which could complicate circumcision
Data sourced from ClinicalTrials.gov (NCT02443792). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.