Dermatitis, ContactPhase 3NCT05492721
Comparing Tissue Adhesives in Port Site Closure
A Phase 3 study testing Dermabond (2-Octylcyanoacrylate), Swiftset (N-butyl-2-cyanoacrylate) and Liquiband (2-Octylcyanoacrylate) in people with Dermatitis, Contact, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dermatitis, Contact
- What is being tested?
- Dermabond (2-Octylcyanoacrylate), Swiftset (N-butyl-2-cyanoacrylate) and Liquiband (2-Octylcyanoacrylate)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2022to 23 Jun 2025
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 or older
- undergoing an elective laparoscopic or robotic abdominal surgery
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Tissue Adhesives in Port Site Closure: A Randomized Controlled Trial
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
- 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.
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.
- Conditions
- Dermatitis, Contact
- Being tested
- Dermabond (2-Octylcyanoacrylate), Swiftset (N-butyl-2-cyanoacrylate), Liquiband (2-Octylcyanoacrylate)
- Keywords
- GLUE, SURGICAL GLUE, DERMABOND, DERMATITIS
- Medical subject headings
- Dermatitis, Contact, Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dermabond (2-Octylcyanoacrylate)Device
Incisions on left will have one glue and on right will have the other glue
Swiftset (N-butyl-2-cyanoacrylate)Device
Incisions on left will have one glue and on right will have the other glue
Liquiband (2-Octylcyanoacrylate)Device
Incisions on left will have one glue and on right will have the other glue
| Study group | Role | What they receive |
|---|---|---|
| Dermabond (2-Octylcyanoacrylate) | Active comparator | Dermabond over incisions Receives: Device: Dermabond (2-Octylcyanoacrylate) |
| Swiftset (N-butyl-2-cyanoacrylate) | Active comparator | Swiftset over incisions Receives: Device: Swiftset (N-butyl-2-cyanoacrylate) |
| Liquiband (2-Octylcyanoacrylate) | Active comparator | Liquiband over incisions Receives: Device: Liquiband (2-Octylcyanoacrylate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Develop Contact Dermatitis
Contact Dermatitis is defined as erythema or rash around incisions
Measured: 6 weeks
Secondary outcomes (3)
Mean Diameter of Erythema
mean diameter of erythema around incisions for those with contact dermatitis
Measured: 6 weeks
Number of Participants With Wound Dehiscence
Measured: 6 weeks
Number of Participants With Surgical Site Infection
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start29 Jun 2022
- Primary completion23 Jun 2025
- Study completion23 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dermatitis, ContactStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each subject will have both glue types and serve as their own control
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Holihan, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05492721
- Sponsor's protocol ID
- HSC-MS-22-0143
- Status last verified
- Jun 2026
- First submitted
- 5 Aug 2022
- Last updated
- 26 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Tissue Adhesives in Port Site Closure: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05492721
- Acronym / sponsor ID
- HSC-MS-22-0143
- Conditions
- Dermatitis, Contact
- Keywords
- GLUE, SURGICAL GLUE, DERMABOND, DERMATITIS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 23 Jun 2025 (actual)
- Study completion
- 23 Jun 2025 (actual)
- First posted
- 8 Aug 2022 (actual)
- Results
- Posted 29 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Each subject will have both glue types and serve as their own control
| Arm | Type | Receives |
|---|---|---|
| Dermabond (2-Octylcyanoacrylate) | Active comparator | Device: Dermabond (2-Octylcyanoacrylate)Dermabond over incisions |
| Swiftset (N-butyl-2-cyanoacrylate) | Active comparator | Device: Swiftset (N-butyl-2-cyanoacrylate)Swiftset over incisions |
| Liquiband (2-Octylcyanoacrylate) | Active comparator | Device: Liquiband (2-Octylcyanoacrylate)Liquiband over incisions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 or older
- undergoing an elective laparoscopic or robotic abdominal surgery
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dermabond (2-Octylcyanoacrylate)Incisions on left will have one glue and on right will have the other glue | Device | Dermabond (2-Octylcyanoacrylate) |
| Swiftset (N-butyl-2-cyanoacrylate)Incisions on left will have one glue and on right will have the other glue | Device | Swiftset (N-butyl-2-cyanoacrylate) |
| Liquiband (2-Octylcyanoacrylate)Incisions on left will have one glue and on right will have the other glue | Device | Liquiband (2-Octylcyanoacrylate) |
Primary outcome
Number of Participants Who Develop Contact Dermatitis
Time frame: 6 weeks
Contact Dermatitis is defined as erythema or rash around incisions
3 secondary outcomes
Mean Diameter of Erythema
Time frame: 6 weeks
Number of Participants With Wound Dehiscence
Time frame: 6 weeks
Number of Participants With Surgical Site Infection
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Dermatitis, Contact
Enrolling by invitation
Neonatal Intensive Care Unit (NICU) Diaper Dermatitis: Prevention and Treatment With Airtime
Diaper Dermatitis
Not yet recruiting
Use of Silk Fibroin Dressings in Primary Total Hip Arthroplasty
Allergic Contact Dermatitis (ACD)
Recruiting
Glycyrrhetinic Acid and Acute Irritant Dermatitis
Irritant Contact Dermatitis
Recruiting
Exploring Skin Barrier Function, Recurrence of Diabetes Device-Related Contact Dermatitis, and Evaluation of Hydrocolloid and Silicone-Based Patches for Its Prevention in Children and Adolescents With Type 1 Diabetes
Contact Dermatitis, Type 1 Diabetes Mellitus
Not yet recruitingPhase 4
Reliability of Expired Allergens in Patch Testing: A Comparative Study With Non-Expired Series
Allergic Contact Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dermabond (2-Octylcyanoacrylate), Swiftset (N-butyl-2-cyanoacrylate) and Liquiband (2-Octylcyanoacrylate) in people with Dermatitis, Contact, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Develop Contact Dermatitis (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.