Trial Outcomes & Findings for Phase 4 Field Trial of the Unicirc Instrument With Tissue Adhesive (NCT NCT02091726)

Results Overview

Intraoperative time, total

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

110 participants

Primary outcome timeframe

1 hour

Results posted on

2018-09-06

Participant Flow

Three generalist physicians (GPs) performed the circumcisions in individual consultation rooms in their own primary health care clinic. The study took place between January 20 and July 4, 2014.

Participant milestones

Participant milestones
Measure	Unicirc With Tissue Adhesive Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate Unicirc instrument plus cyanoacrylate tissue adhesive: Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive
Overall Study STARTED	110
Overall Study 1 Week Followup	110
Overall Study 4 Week Followup	104
Overall Study COMPLETED	104
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Unicirc With Tissue Adhesive Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate Unicirc instrument plus cyanoacrylate tissue adhesive: Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive
Overall Study Lost to Follow-up	6

Baseline Characteristics

Phase 4 Field Trial of the Unicirc Instrument With Tissue Adhesive

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Unicirc With Tissue Adhesive n=110 Participants Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate Unicirc instrument plus cyanoacrylate tissue adhesive: Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	110 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	110 Participants n=5 Participants
Region of Enrollment South Africa	110 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 hour

Intraoperative time, total

Outcome measures

Outcome measures
Measure	Unicirc With Tissue Adhesive n=110 Participants Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate Unicirc instrument plus cyanoacrylate tissue adhesive: Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive
Time for Procedure	9.0 Min Interval 9.0 to 10.0

SECONDARY outcome

Timeframe: 4 weeks

Definition: Completely epithelialized; no superficial ulcerations or granulation tissue present

Outcome measures

Outcome measures
Measure	Unicirc With Tissue Adhesive n=104 Participants Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate Unicirc instrument plus cyanoacrylate tissue adhesive: Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive
Completely Healed at 4 Weeks	94 participants

SECONDARY outcome

Timeframe: 4 weeks

Population: Wound dehiscence \< 2 cm. None required treatment. There were no participants with wound dehiscence \> 2 cm.

Wound separation caused by adhesive failure (minor --requires no treatment)

Outcome measures

Outcome measures
Measure	Unicirc With Tissue Adhesive n=110 Participants Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate Unicirc instrument plus cyanoacrylate tissue adhesive: Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive
Wound Separation Separation > 2 cm longitudinally	0 participants
Wound Separation Separation < 2 cm longitudinally	5 participants

SECONDARY outcome

Timeframe: 4 weeks

Population: 104 men came for their 4-week followup but the doctor(s) failed to note the cosmetic result in 2 men.

Excellent: scar line straight without any irregularity Irregular: Some irregularity to scar line Scalloped: wavy appearane to scar line

Outcome measures

Outcome measures
Measure	Unicirc With Tissue Adhesive n=102 Participants Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate Unicirc instrument plus cyanoacrylate tissue adhesive: Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive
Cosmetic Result Excellent	101 participants

SECONDARY outcome

Timeframe: 4 weeks

Population: 104 men came for their 4-week followup, but 1 man did not complete the satisfaction questions.

Yes to both of the following questions: Are you fully satisfied with your circumcision result? Would you recommend circumcision to friends or family?

Outcome measures

Outcome measures
Measure	Unicirc With Tissue Adhesive n=103 Participants Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate Unicirc instrument plus cyanoacrylate tissue adhesive: Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive
Participant Fully Satisfied and Would Recommend to Friends and Family	103 participants

Adverse Events

Unicirc With Tissue Adhesive

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Unicirc With Tissue Adhesive n=110 participants at risk Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate Unicirc instrument plus cyanoacrylate tissue adhesive: Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive
Surgical and medical procedures Bleeding requiring suture	4.5% 5/110 • Number of events 5 • Time period: 4 weeks Active followup of volunteers at 1 and 4 weeks
Surgical and medical procedures Infection requiring antibiotics	1.8% 2/110 • Number of events 2 • Time period: 4 weeks Active followup of volunteers at 1 and 4 weeks

Additional Information

Peter S. Millard, MD, PhD

University of New England

Phone: 2072992131

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place