Unicirc vs Open Surgical Circumcision (Unicirc004)

Simunye Primary Health Care

Status and phase: Completed; Phase 4

Conditions: Circumcision, Male

Treatments: Procedure: Unicirc with tissue adhesive; Procedure: Open Surgical

Study type: Interventional

Funder types: Other

Identifiers

NCT02443792

Unicirc004

Details and patient eligibility

About

RCT of Unicirc under topical anesthetic w/ cyanoacrylate wound sealing vs. open surgical circumcision under local anesthetic with suturing.

Enrollment: 75 patients

Sex: Male

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

75 participants in 2 patient groups

Unicirc with tissue adhesive

Experimental group

Description:

Unicirc under topical anesthetic w/ cyanoacrylate wound sealing

Treatment:

Procedure: Unicirc with tissue adhesive

Open Surgical

Active Comparator group

Description:

Open surgical circumcision under local anesthetic with suturing

Treatment:

Procedure: Open Surgical