Trial Outcomes & Findings for A Randomized Controlled Trial of Open Surgical vs. Rapid, Minimally-invasive Voluntary Adult Male Circumcision (NCT NCT01877408)

NCT ID: NCT01877408

Last Updated: 2018-10-02

Results Overview

Amount of time from first manipulation of tissue under local anesthesia to dressing

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 150 participants
• Primary outcome timeframe: 1 hour
• Results posted on: 2018-10-02

Participant Flow

Recruitment occurred between 31 May, 2013 and 26 June, 2013. Participants were recruited via posters at two affiliated primary care clinics in Cape Town.

Healthy, uncircumcised men who were at least 18 years of age were eligible to participate in the study. All those who were enrolled and who showed up for their procedure were included in the study.

Participant milestones

Measure	Open Surgical Circumcision The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.	Unicirc Device With Tissue Adhesive Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
Overall Study STARTED	50	100
Overall Study COMPLETED	50	98
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Measure	Open Surgical Circumcision The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.	Unicirc Device With Tissue Adhesive Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
Overall Study Lost to Follow-up	0	2

Baseline Characteristics

A Randomized Controlled Trial of Open Surgical vs. Rapid, Minimally-invasive Voluntary Adult Male Circumcision

Baseline characteristics by cohort

Measure	Open Surgical Circumcision n=50 Participants The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.	Unicirc Device With Tissue Adhesive n=100 Participants Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.	Total n=150 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	49 Participants n=5 Participants	100 Participants n=7 Participants	149 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 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	100 Participants n=7 Participants	150 Participants n=5 Participants
Region of Enrollment South Africa	50 participants n=5 Participants	100 participants n=7 Participants	150 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 hour

Amount of time from first manipulation of tissue under local anesthesia to dressing

Outcome measures

Measure	Open Surgical Circumcision n=50 Participants The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.	Unicirc Device With Tissue Adhesive n=100 Participants Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
Intraoperative Duration Procedure without frenulectomy (n=44,96)	22.6 minutes Inter-Quartile Range 8.6 • Interval 14.0 to 31.2	13.0 minutes Inter-Quartile Range 4.5 • Interval 8.5 to 17.5
Intraoperative Duration Procedure with frenulectomy (n=6,4)	25.0 minutes Interval 7.0 to 43.0	28.6 minutes Interval 10.9 to 46.3

SECONDARY outcome

Timeframe: 1 year

Population: The four physicians that participated in this study performed both procedures (i.e. open surgical and Unicirc) on study participants. Three physicians had significant previous (non-study) experience performing open surgical circumcisions. All four had no to very limited previous experience performing Unicirc circumcisions.

Evaluated by doctor survey based on 5 point Likert scale

1. Unicirc is much easier

2. Unicirc is easier

3. Neutral

4. Open surgical is easier

5. Open surgical is much easier

Outcome measures

Measure	Open Surgical Circumcision n=4 Participants The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.	Unicirc Device With Tissue Adhesive Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
Difficulty in Learning and Performing Technique	2 units on Likert scale Interval 1.0 to 5.0	—

SECONDARY outcome

Timeframe: Within 4 weeks after surgery

Outcome measures

Measure	Open Surgical Circumcision n=50 Participants The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.	Unicirc Device With Tissue Adhesive n=98 Participants Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
Number of Participants With Complete Wound Healing by Post-Surgery Week 4	49 participants	89 participants

SECONDARY outcome

Timeframe: Within 2 days after surgery

Pain experienced during and after the procedure evaluated using a 10 point pain scale (0 signifies no pain and 10 signifies maximal pain

Outcome measures

Measure	Open Surgical Circumcision n=50 Participants The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.	Unicirc Device With Tissue Adhesive n=100 Participants Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
Pain Experienced Pain in first 24 hours post-op	3.1 units on a 10-point pain scale Standard Deviation 2.4	4.2 units on a 10-point pain scale Standard Deviation 2.7
Pain Experienced Pain at 48 hours post-op	1.2 units on a 10-point pain scale Standard Deviation 2.0	0.7 units on a 10-point pain scale Standard Deviation 1.6

SECONDARY outcome

Timeframe: Within 6 weeks after surgery

Patient satisfaction evaluated with questionnaire using satisfaction scale

1. Very satisfied

2. Satisfied

3. Not satisfied

Outcome measures

Measure	Open Surgical Circumcision n=50 Participants The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.	Unicirc Device With Tissue Adhesive n=98 Participants Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
Overall Patient Satisfaction Very satisfied	40 participants	78 participants
Overall Patient Satisfaction Satisfied	8 participants	15 participants
Overall Patient Satisfaction Not satisfied	2 participants	5 participants

SECONDARY outcome

Timeframe: Within 6 weeks after surgery

Cosmetic result evaluated by classification of scar line as regular (straight without any irregularity), irregular (not completely straight), or scalloped (with a wavy appearance)

Outcome measures

Measure	Open Surgical Circumcision n=50 Participants The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.	Unicirc Device With Tissue Adhesive n=98 Participants Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
Cosmetic Result Regular	20 participants	79 participants
Cosmetic Result Irregular	8 participants	12 participants
Cosmetic Result Scalloped	22 participants	7 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Number of participants with intraoperative and post-operative adverse events, such as bleeding, hematoma, and infection

Outcome measures

Measure	Open Surgical Circumcision n=50 Participants The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.	Unicirc Device With Tissue Adhesive n=100 Participants Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
Number of Participants With Adverse Events Mild bleeding	1 participants	4 participants
Number of Participants With Adverse Events Moderate bleeding (suturing required)	2 participants	10 participants
Number of Participants With Adverse Events Hematoma	0 participants	4 participants
Number of Participants With Adverse Events Infection (antibiotic required)	6 participants	10 participants

Adverse Events

Open Surgical Circumcision

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Unicirc Device With Tissue Adhesive

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Open Surgical Circumcision n=50 participants at risk The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.	Unicirc Device With Tissue Adhesive n=100 participants at risk Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
Surgical and medical procedures Mild post-operative bleeding	2.0% 1/50 • Number of events 1 • 1 year	4.0% 4/100 • Number of events 4 • 1 year
Surgical and medical procedures Moderate post-operative bleeding	4.0% 2/50 • Number of events 2 • 1 year	10.0% 10/100 • Number of events 10 • 1 year
Surgical and medical procedures Hematoma	0.00% 0/50 • 1 year	4.0% 4/100 • Number of events 4 • 1 year
Surgical and medical procedures Post-operative infection	12.0% 6/50 • Number of events 6 • 1 year	10.0% 10/100 • Number of events 10 • 1 year

Additional Information

Dr. Peter Millard

University of New England

Phone: 2078663503

Email: pmillard@mac.com

Results disclosure agreements

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