Trial Outcomes & Findings for Comparing Tissue Adhesives in Port Site Closure (NCT NCT05492721)
NCT ID: NCT05492721
Last Updated: 2026-05-29
Results Overview
Contact Dermatitis is defined as erythema or rash around incisions
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
180 participants
Primary outcome timeframe
6 weeks
Results posted on
2026-05-29
Participant Flow
The hospital discontinued use of SwiftSet (N-butyl-2-cyanoacrylate) prior to study initiation; therefore, no participants were enrolled in this arm. A total of 180 participants were enrolled. Each participant served as their own control. For each participant two surgical glue types were used, one on each half of their abdomen
Unit of analysis: incisions
Participant milestones
| Measure |
Dermabond (2-Octylcyanoacrylate)
Dermabond over incisions
Dermabond (2-Octylcyanoacrylate): Incisions on left will have one glue and on right will have the other glue
|
Swiftset (N-butyl-2-cyanoacrylate)
Swiftset over incisions
Swiftset (N-butyl-2-cyanoacrylate): Incisions on left will have one glue and on right will have the other glue
|
Liquiband (2-Octylcyanoacrylate)
Liquiband over incisions
Liquiband (2-Octylcyanoacrylate): Incisions on left will have one glue and on right will have the other glue
|
|---|---|---|---|
|
Overall Study
STARTED
|
180 180
|
0 -0
|
180 180
|
|
Overall Study
COMPLETED
|
179 179
|
0 0
|
179 179
|
|
Overall Study
NOT COMPLETED
|
1 1
|
0 0
|
1 1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Participants
n=180 Participants
All participants received both interventions. One surgical glue (Dermabond \[2-Octylcyanoacrylate\]) was applied to incisions on one side of the abdomen and the other glue (Liquiband \[2-Octylcyanoacrylate\]) was applied to the opposite side.
|
|---|---|
|
Age, Continuous
|
47 years
n=180 Participants
|
|
Sex: Female, Male
Female
|
131 Participants
n=180 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=180 Participants
|
|
Region of Enrollment
United States
|
180 participants
n=180 Participants
|
|
Type of Surgery
Cholecystectomy
|
3 Participants
n=180 Participants
|
|
Type of Surgery
Duodenal Switch
|
12 Participants
n=180 Participants
|
|
Type of Surgery
Gastric Bypass
|
56 Participants
n=180 Participants
|
|
Type of Surgery
Hiatal Hernia Repair
|
9 Participants
n=180 Participants
|
|
Type of Surgery
Inguinal Hernia Repair
|
17 Participants
n=180 Participants
|
|
Type of Surgery
Revisional Bariatric
|
35 Participants
n=180 Participants
|
|
Type of Surgery
Sleeve Gastrectomy
|
40 Participants
n=180 Participants
|
|
Type of Surgery
Small Bowl Resection
|
2 Participants
n=180 Participants
|
|
Type of Surgery
Ventral Hernia Repair
|
6 Participants
n=180 Participants
|
PRIMARY outcome
Timeframe: 6 weeksContact Dermatitis is defined as erythema or rash around incisions
Outcome measures
| Measure |
Dermabond (2-Octylcyanoacrylate)
n=179 Participants
Dermabond over incisions
Dermabond (2-Octylcyanoacrylate): Incisions on left will have one glue and on right will have the other glue
|
Liquiband (2-Octylcyanoacrylate)
n=179 Participants
Liquiband over incisions
Liquiband (2-Octylcyanoacrylate): Incisions on left will have one glue and on right will have the other glue
|
|---|---|---|
|
Number of Participants Who Develop Contact Dermatitis
|
21 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: This outcome measure was pre-specified in the protocol, however no data were collected for this measure because the assessment was not performed. Data collection and analysis for this outcome measure will not be conducted in the future. Therefore, no participants were measured or analyzed for this outcome measure.
mean diameter of erythema around incisions for those with contact dermatitis
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 weeksOutcome measures
| Measure |
Dermabond (2-Octylcyanoacrylate)
n=179 Participants
Dermabond over incisions
Dermabond (2-Octylcyanoacrylate): Incisions on left will have one glue and on right will have the other glue
|
Liquiband (2-Octylcyanoacrylate)
n=179 Participants
Liquiband over incisions
Liquiband (2-Octylcyanoacrylate): Incisions on left will have one glue and on right will have the other glue
|
|---|---|---|
|
Number of Participants With Wound Dehiscence
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 weeksOutcome measures
| Measure |
Dermabond (2-Octylcyanoacrylate)
n=179 Participants
Dermabond over incisions
Dermabond (2-Octylcyanoacrylate): Incisions on left will have one glue and on right will have the other glue
|
Liquiband (2-Octylcyanoacrylate)
n=179 Participants
Liquiband over incisions
Liquiband (2-Octylcyanoacrylate): Incisions on left will have one glue and on right will have the other glue
|
|---|---|---|
|
Number of Participants With Surgical Site Infection
|
0 Participants
|
0 Participants
|
Adverse Events
Dermabond (2-Octylcyanoacrylate)
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Liquiband (2-Octylcyanoacrylate)
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Swiftset (N-butyl-2-cyanoacrylate)
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 |
Dermabond (2-Octylcyanoacrylate)
n=180 participants at risk
Dermabond over incisions
Dermabond (2-Octylcyanoacrylate): Incisions on left will have one glue and on right will have the other glue
|
Liquiband (2-Octylcyanoacrylate)
n=180 participants at risk
Liquiband over incisions
Liquiband (2-Octylcyanoacrylate): Incisions on left will have one glue and on right will have the other glue
|
Swiftset (N-butyl-2-cyanoacrylate)
Swiftset over incisions Swiftset (N-butyl-2-cyanoacrylate): Incisions on left will have one glue and on right will have the other glue
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Contact Dermatitis
|
11.7%
21/180 • Up to 6 weeks
Adverse Events are only reported for the two arms participants were enrolled in. The hospital discontinued use of SwiftSet (N-butyl-2-cyanoacrylate) prior to study initiation; therefore, zero participants were enrolled in this arm.
|
10.0%
18/180 • Up to 6 weeks
Adverse Events are only reported for the two arms participants were enrolled in. The hospital discontinued use of SwiftSet (N-butyl-2-cyanoacrylate) prior to study initiation; therefore, zero participants were enrolled in this arm.
|
—
0/0 • Up to 6 weeks
Adverse Events are only reported for the two arms participants were enrolled in. The hospital discontinued use of SwiftSet (N-butyl-2-cyanoacrylate) prior to study initiation; therefore, zero participants were enrolled in this arm.
|
Additional Information
Julie Holihan, MD
The University of Texas Health Science Center at Houston
Phone: 7135007245
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place