CClinicalTrials.gg
CompletedNCT05492721Updated Jun 26, 2026Results posted

Comparing Tissue Adhesives in Port Site Closure

A Phase 3 interventional study of Dermabond (2-Octylcyanoacrylate) and Swiftset (N-butyl-2-cyanoacrylate) in Dermatitis, Contact, sponsored by The University of Texas Health Science Center, Houston. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-26.

Sponsored by The University of Texas Health Science Center, Houston · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a multi-center randomized controlled trial to evaluate two different methods of reinforcing surgical port site closure: 2-Octylcyanoacrylate and n-butyl-2-cyanoacrylate.

Read the detailed description

Study Design

This is a multi-center randomized controlled trial to evaluate two different methods of reinforcing surgical port site closure: 2-Octylcyanoacrylate and n-butyl-2-cyanoacrylate.

Methods

Inclusion Criteria All adult patients undergoing an elective laparoscopic or robotic abdominal surgery with the Minimally Invasive Surgeons of Texas (MIST) either at Texas Medical Center or Sugar Land will be eligible.

Exclusion criteria

  1. Patients unlikely to follow-up (live out of state, unable to be reached by phone or email)
  2. Patients with a known allergy to 2-Octylcyanoacrylate or N-butyl-2-cyanoacrylate.

Treatment Groups Eligible patients will be approached by research staff either in clinic or in pre-operative holding for trial enrollment. Each patient will serve as their own control. Enrolled patients will have both surgical glue types used, one on each half of their abdomen. The side for each glue will be randomly assigned by the day of the month. On odd days, 2-Octylcyanoacrylate will go on the patient's left abdomen. On even days, 2-Octylcyanoacrylate will go on the patient's right abdomen. If there is an odd number of incisions, the extra incision will be included on the patient's left.

All incisions will be closed with Monocryl. Closed incisions will be covered with skin glue.

Outcome The primary outcome of this trial will be the proportion of patients with contact dermatitis within 6 weeks post-operative. A trained surgical clinician blinded to the treatment arms will collect outcomes at all follow up clinic visits in the first 6 weeks post-operative. Any skin reaction will be documented with photographs.

Secondary outcome will include the diameter of erythema around any skin reaction, or any wound dehiscence or surgical site infection.

02

Conditions studied

  • Dermatitis, Contact

Keywords

  • GLUE
  • SURGICAL GLUE
  • DERMABOND
  • DERMATITIS
03

In context

Dermatitis, Contact

94 studies on the registry are indexed under Dermatitis, Contact; 14 are open to participants now.

This study's enrollment of 180 is above the median of 40 across 75 interventional studies indexed under Dermatitis, Contact.

Browse Dermatitis, Contact studies →

Lead sponsor

The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 18 or older
  • undergoing an elective laparoscopic or robotic abdominal surgery

Exclusion criteria

Exclusion Criteria:

  • Patients unlikely to follow-up (live out of state, unable to be reached by phone or email)
  • Patients with a known allergy to 2-Octylcyanoacrylate or N-butyl-2-cyanoacrylate.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
180 participants (actual)

Study arms

  • Active comparator
    Dermabond (2-Octylcyanoacrylate)

    Dermabond over incisions

    Device: Dermabond (2-Octylcyanoacrylate)

  • Active comparator
    Swiftset (N-butyl-2-cyanoacrylate)

    Swiftset over incisions

    Device: Swiftset (N-butyl-2-cyanoacrylate)

  • Active comparator
    Liquiband (2-Octylcyanoacrylate)

    Liquiband over incisions

    Device: Liquiband (2-Octylcyanoacrylate)

Interventions

  • DeviceDermabond (2-Octylcyanoacrylate)

    Incisions on left will have one glue and on right will have the other glue

  • DeviceSwiftset (N-butyl-2-cyanoacrylate)

    Incisions on left will have one glue and on right will have the other glue

  • DeviceLiquiband (2-Octylcyanoacrylate)

    Incisions on left will have one glue and on right will have the other glue

06

What researchers measure

Primary outcomes

  1. Number of Participants Who Develop Contact Dermatitis

    Contact Dermatitis is defined as erythema or rash around incisions

    Time frame: 6 weeks

Secondary outcomes

  1. Mean Diameter of Erythema

    mean diameter of erythema around incisions for those with contact dermatitis

    Time frame: 6 weeks

  2. Number of Participants With Wound Dehiscence

    Time frame: 6 weeks

  3. Number of Participants With Surgical Site Infection

    Time frame: 6 weeks

07

Results

Posted May 29, 2026

Participant flow

Participant flow — Overall Study
MilestoneDermabond (2-Octylcyanoacrylate)Swiftset (N-butyl-2-cyanoacrylate)Liquiband (2-Octylcyanoacrylate)
Started1800180
Completed1790179
Not completed101

Outcome measures

PrimaryNumber of Participants Who Develop Contact Dermatitis

Contact Dermatitis is defined as erythema or rash around incisions

Time frame:
6 weeks
Reported as:
Count of participants · Participants
Number of Participants Who Develop Contact Dermatitis
ParticipantsDermabond (2-Octylcyanoacrylate)Liquiband (2-Octylcyanoacrylate)
Number of Participants Who Develop Contact Dermatitis2118
SecondaryMean Diameter of Erythema

mean diameter of erythema around incisions for those with contact dermatitis

Time frame:
6 weeks

No measurements were reported for this outcome.

SecondaryNumber of Participants With Wound Dehiscence
Time frame:
6 weeks
Reported as:
Count of participants · Participants
Number of Participants With Wound Dehiscence
ParticipantsDermabond (2-Octylcyanoacrylate)Liquiband (2-Octylcyanoacrylate)
Number of Participants With Wound Dehiscence00
SecondaryNumber of Participants With Surgical Site Infection
Time frame:
6 weeks
Reported as:
Count of participants · Participants
Number of Participants With Surgical Site Infection
ParticipantsDermabond (2-Octylcyanoacrylate)Liquiband (2-Octylcyanoacrylate)
Number of Participants With Surgical Site Infection00

Adverse events

Collected over Up to 6 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Dermabond (2-Octylcyanoacrylate)0/180 (0%)0/180 (0%)21/180 (11.7%)
Liquiband (2-Octylcyanoacrylate)0/180 (0%)0/180 (0%)18/180 (10%)
Swiftset (N-butyl-2-cyanoacrylate)———
Most frequent other events
Most frequent other events
EventDermabond (2-Octylcyanoacrylate)Liquiband (2-Octylcyanoacrylate)Swiftset (N-butyl-2-cyanoacrylate)
Contact DermatitisSkin and subcutaneous tissue disorders21/18018/180—

Baseline characteristics

Participants served as their own control in this split-person design, with each receiving both surgical glue types applied to opposite sides of the abdomen. Baseline characteristics are reported at the participant level using a single group ("All Participants") to avoid double counting.

Age, Continuous
Age, Continuous(years)All Participants
Median47 (37 to 55)
Sex: Female, Male
Sex: Female, Male(Participants)All Participants
Female131
Male49
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)All Participants
Region of Enrollment
Region of Enrollment(participants)All Participants
United States180
Type of Surgery
Type of Surgery(Participants)All Participants
Cholecystectomy3
Duodenal Switch12
Gastric Bypass56
Hiatal Hernia Repair9
Inguinal Hernia Repair17
Revisional Bariatric35
Sleeve Gastrectomy40
Small Bowl Resection2
Ventral Hernia Repair6
08

Study locations

1 site
  • Memorial Hermann
    Houston, Texas 77030, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Sep 18, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05492721
Lead sponsor
The University of Texas Health Science Center, Houston
Responsible party
Julie Holihan (Assistant Professor of Surgery, The University of Texas Health Science Center, Houston) — Principal investigator
First posted
Aug 8, 2022
Start date
Jun 29, 2022
Primary completion
Jun 23, 2025
Completion
Jun 23, 2025
Results posted
May 29, 2026
Last update
Jun 26, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion