Unicirc vs Open Surgical Circumcision

Simunye Primary Health Care75 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Circumcision, Male

Interventions

Unicirc with tissue adhesivePROCEDURE

As above

Open SurgicalPROCEDURE

As above

Eligibility

Sex: MALEMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Lonmin Hospital

Marikana, Northwest, South Africa

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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