Phase 4
Completed N=75
Unicirc vs Open Surgical Circumcision
Circumcision, Male
Source: ClinicalTrials.gov NCT02443792 ↗
Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcomePrimary: Time Elapsed From First Clamp (Surgical) or Start of Insertion of Bell (Unicirc) to Beginning of Wound Dressing — 12; 25 Minutes
Summary
RCT of Unicirc under topical anesthetic w/ cyanoacrylate wound sealing vs. open surgical circumcision under local anesthetic with suturing.
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 | — |
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. Informational only — not medical advice.