Trial Outcomes & Findings for Unicirc vs Open Surgical Circumcision (NCT NCT02443792)

NCT ID: NCT02443792

Last Updated: 2018-10-03

Results Overview

Time elapsed from first clamp (surgical) or start of insertion of bell (Unicirc) to beginning of wound dressing

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 75 participants
• Primary outcome timeframe: Up to 30 minutes
• Results posted on: 2018-10-03

Participant Flow

Participant milestones

Measure	Unicirc With Tissue Adhesive Unicirc under topical anesthetic w/ cyanoacrylate wound sealing Unicirc with tissue adhesive: As above	Open Surgical Open surgical circumcision under local anesthetic with suturing Open Surgical: As above
Overall Study STARTED	50	25
Overall Study COMPLETED	43	23
Overall Study NOT COMPLETED	7	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Unicirc vs Open Surgical Circumcision

Baseline characteristics by cohort

Measure	Unicirc With Tissue Adhesive n=50 Participants Unicirc under topical anesthetic w/ cyanoacrylate wound sealing Unicirc with tissue adhesive: As above	Open Surgical n=25 Participants Open surgical circumcision under local anesthetic with suturing Open Surgical: As above	Total n=75 Participants Total of all reporting groups
Age, Customized Age 18-25	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants
Age, Customized Age 26-35	19 participants n=5 Participants	12 participants n=7 Participants	31 participants n=5 Participants
Age, Customized Age 36+	28 participants n=5 Participants	11 participants n=7 Participants	39 participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	50 Participants n=5 Participants	25 Participants n=7 Participants	75 Participants n=5 Participants
Region of Enrollment South Africa	50 participants n=5 Participants	25 participants n=7 Participants	75 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 30 minutes

Time elapsed from first clamp (surgical) or start of insertion of bell (Unicirc) to beginning of wound dressing

Outcome measures

Measure	Unicirc With Tissue Adhesive n=50 Participants Unicirc under topical anesthetic w/ cyanoacrylate wound sealing Unicirc with tissue adhesive: As above	Open Surgical n=25 Participants Open surgical circumcision under local anesthetic with suturing Open Surgical: As above
Time Elapsed From First Clamp (Surgical) or Start of Insertion of Bell (Unicirc) to Beginning of Wound Dressing	12 Minutes Interval 11.0 to 17.0	25 Minutes Interval 21.0 to 35.0

SECONDARY outcome

Timeframe: Up to 30 minutes

Self-described pain severity during procedure (scale 1 to 10). 0=no pain, 5=moderate pain, 10=worst pain ever

Outcome measures

Measure	Unicirc With Tissue Adhesive n=50 Participants Unicirc under topical anesthetic w/ cyanoacrylate wound sealing Unicirc with tissue adhesive: As above	Open Surgical n=25 Participants Open surgical circumcision under local anesthetic with suturing Open Surgical: As above
Surgical Pain 0=no Pain; 10=Worst Pain Ever	1.7 units on a scale Standard Deviation 1.3	1.9 units on a scale Standard Deviation 2.4

SECONDARY outcome

Timeframe: At the 4-week followup visit

Number of participants who were completely healed at 4 weeks

Outcome measures

Measure	Unicirc With Tissue Adhesive n=50 Participants Unicirc under topical anesthetic w/ cyanoacrylate wound sealing Unicirc with tissue adhesive: As above	Open Surgical n=25 Participants Open surgical circumcision under local anesthetic with suturing Open Surgical: As above
Completely Healed at 4 Weeks	39 participants	16 participants

SECONDARY outcome

Timeframe: Up to 4 weeks

Proportion experiencing wound dehiscence (< 2 cm vs > 2 cm)

Outcome measures

Measure	Unicirc With Tissue Adhesive n=50 Participants Unicirc under topical anesthetic w/ cyanoacrylate wound sealing Unicirc with tissue adhesive: As above	Open Surgical n=25 Participants Open surgical circumcision under local anesthetic with suturing Open Surgical: As above
Wound Dehiscence Dehiscence < 2 cm longitudinally	14 participants	4 participants
Wound Dehiscence Dehiscence > 2 cm longitudinally	0 participants	0 participants

SECONDARY outcome

Timeframe: Up to 4 weeks

Proportion experiencing post-op infection, determined clinically (treated with antibiotics)

Outcome measures

Measure	Unicirc With Tissue Adhesive n=50 Participants Unicirc under topical anesthetic w/ cyanoacrylate wound sealing Unicirc with tissue adhesive: As above	Open Surgical n=25 Participants Open surgical circumcision under local anesthetic with suturing Open Surgical: As above
Infection	0 participants	0 participants

Adverse Events

Unicirc With Tissue Adhesive

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Open Surgical

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Unicirc With Tissue Adhesive n=50 participants at risk Unicirc under topical anesthetic w/ cyanoacrylate wound sealing Unicirc with tissue adhesive: As above	Open Surgical n=25 participants at risk Open surgical circumcision under local anesthetic with suturing Open Surgical: As above
Surgical and medical procedures Post-op bleeding	2.0% 1/50 • Number of events 1 • Any any time during study (4-6 weeks)	0.00% 0/25 • Any any time during study (4-6 weeks)
Surgical and medical procedures Intraoperative bleeding requiring sutures	4.0% 2/50 • Number of events 2 • Any any time during study (4-6 weeks)	0.00% 0/25 • Any any time during study (4-6 weeks)

Additional Information

Dr. Justin Shenje

U of Cape Town

Phone: 0027788938497

Email: justintshenje@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place