N/A
N=110
Phase 4 Field Trial of the Unicirc Instrument With Tissue Adhesive
Male Circumcision
Bottom Line
View on ClinicalTrials.gov: NCT02091726 ↗Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcome: Primary: Time for Procedure — 9.0 Min
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Unicirc instrument plus cyanoacrylate tissue adhesive (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Simunye Primary Health Care
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time for Procedure |
9.0 | — |
| SECONDARY Completely Healed at 4 Weeks |
94 | — |
| SECONDARY Wound Separation |
0; 5 | — |
| SECONDARY Cosmetic Result Excellent |
101 | — |
| SECONDARY Participant Fully Satisfied and Would Recommend to Friends and Family |
103 | — |
Summary
This is a field trial of the Unicirc instrument to excise the foreskin, plus use of cyanoacrylate tissue adhesive to seal the wound.
Eligibility Criteria
Inclusion Criteria
- Men at least 18 years of age
Exclusion Criteria
- Poor general health
- Anatomical abnormalities that would complicate circumcision
- Bleeding disorder
- Ongoing infection
- Cannot attend followup visits
Data sourced from ClinicalTrials.gov (NCT02091726). 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.