Trial Outcomes & Findings for Rapid, Minimally-invasive Voluntary Adult Male Circumcision (NCT NCT01998360)
NCT ID: NCT01998360
Last Updated: 2018-10-02
Results Overview
The number of minutes required to perform the surgical procedure
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
1 hour
Results posted on
2018-10-02
Participant Flow
Participant milestones
| Measure |
Unicirc With Tissue Adhesive
Excision of foreskin with Unicirc device and sealing wound with tissue adhesive
Unicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive
|
Surgical Control
Surgical circumcision using forceps guided, dorsal slit, or sleeve method
Surgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rapid, Minimally-invasive Voluntary Adult Male Circumcision
Baseline characteristics by cohort
| Measure |
Unicirc With Tissue Adhesive
n=50 Participants
Excision of foreskin with Unicirc device and sealing wound with tissue adhesive
Unicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive
|
Surgical Control
n=50 Participants
Surgical circumcision using forceps guided, dorsal slit, or sleeve method
Surgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions.
|
Total
n=100 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
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 hourThe number of minutes required to perform the surgical procedure
Outcome measures
| Measure |
Unicirc With Tissue Adhesive
n=50 Participants
Excision of foreskin with Unicirc device and sealing wound with tissue adhesive
Unicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive
|
Surgical Control
n=50 Participants
Surgical circumcision using forceps guided, dorsal slit, or sleeve method
Surgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions.
|
|---|---|---|
|
Intraoperative Duration
|
9.0 Min
Interval 8.5 to 10.0
|
22.6 Min
Interval 18.4 to 27.0
|
SECONDARY outcome
Timeframe: 1 monthBleeding, hematoma, infection and other rare adverse events
Outcome measures
| Measure |
Unicirc With Tissue Adhesive
n=50 Participants
Excision of foreskin with Unicirc device and sealing wound with tissue adhesive
Unicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive
|
Surgical Control
n=50 Participants
Surgical circumcision using forceps guided, dorsal slit, or sleeve method
Surgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions.
|
|---|---|---|
|
Number of Participants With Adverse Events
|
4 participants
|
9 participants
|
SECONDARY outcome
Timeframe: During procedure (up to 1 hour)Number of ml of blood lost during the procedure, as assessed by the surgeon
Outcome measures
| Measure |
Unicirc With Tissue Adhesive
n=50 Participants
Excision of foreskin with Unicirc device and sealing wound with tissue adhesive
Unicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive
|
Surgical Control
n=50 Participants
Surgical circumcision using forceps guided, dorsal slit, or sleeve method
Surgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions.
|
|---|---|---|
|
Blood Loss
|
1.5 ml
Interval 1.5 to 1.5
|
5.5 ml
Interval 5.5 to 12.0
|
SECONDARY outcome
Timeframe: 1 monthThe number of participants with complete epithelialization (completely healed) at 4 weeks
Outcome measures
| Measure |
Unicirc With Tissue Adhesive
n=50 Participants
Excision of foreskin with Unicirc device and sealing wound with tissue adhesive
Unicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive
|
Surgical Control
n=50 Participants
Surgical circumcision using forceps guided, dorsal slit, or sleeve method
Surgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions.
|
|---|---|---|
|
Number of Participants With Complete Epithelialization (Completely Healed) at 4 Weeks
|
49 participants
|
49 participants
|
SECONDARY outcome
Timeframe: 6 weeksRegular: scar line straight without any irregularity Irregular: Some irregularity to scar line Scalloped: wavy appearane to scar line
Outcome measures
| Measure |
Unicirc With Tissue Adhesive
n=50 Participants
Excision of foreskin with Unicirc device and sealing wound with tissue adhesive
Unicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive
|
Surgical Control
n=50 Participants
Surgical circumcision using forceps guided, dorsal slit, or sleeve method
Surgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions.
|
|---|---|---|
|
Cosmetic Result
Regular
|
50 participants
|
20 participants
|
|
Cosmetic Result
Irregular
|
0 participants
|
8 participants
|
|
Cosmetic Result
Scalloped
|
0 participants
|
22 participants
|
Adverse Events
Unicirc With Tissue Adhesive
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Surgical Control
Serious events: 0 serious events
Other events: 9 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
Excision of foreskin with Unicirc device and sealing wound with tissue adhesive
Unicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive
|
Surgical Control
n=50 participants at risk
Surgical circumcision using forceps guided, dorsal slit, or sleeve method
Surgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions.
|
|---|---|---|
|
Blood and lymphatic system disorders
Post-op bleeding or hematoma
|
4.0%
2/50 • Number of events 2
|
6.0%
3/50 • Number of events 3
|
|
Infections and infestations
Post-op infection
|
4.0%
2/50 • Number of events 2
|
12.0%
6/50 • Number of events 6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place