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Tissue Adhesive

Tissue Adhesives for Surgical Port Closure

Phase 3
Recruiting
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
undergoing an elective laparoscopic or robotic abdominal surgery
18 or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing two different ways to close surgical ports. One is 2-Octylcyanoacrylate and the other is n-butyl-2-cyanoacrylate.

Who is the study for?
This trial is for adults over 18 who are scheduled for elective laparoscopic or robotic abdominal surgery. It's not suitable for those with allergies to the tissue adhesives being tested or individuals who may not be able to attend follow-up appointments, such as living out of state.
What is being tested?
The study compares two types of tissue adhesives: 2-Octylcyanoacrylate and N-butyl-2-cyanoacrylate, used in closing surgical port sites after abdominal procedures. Participants will be randomly assigned one of these methods.
What are the potential side effects?
Potential side effects from the adhesives could include skin irritation, allergic reactions at the application site, redness, swelling, or discomfort around the closed incision.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for a minimally invasive abdominal surgery.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
proportion of patients who develop contact dermatitis
Secondary study objectives
mean diameter of erythema
proportion of patients with surgical site infection
proportion of patients with wound dehiscence

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Group I: DermabondActive Control2 Interventions
Dermabond over incisions
Group II: SwiftsetActive Control2 Interventions
Swiftset over incisions

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
957 Previous Clinical Trials
347,676 Total Patients Enrolled

Media Library

2-Octylcyanoacrylate (Tissue Adhesive) Clinical Trial Eligibility Overview. Trial Name: NCT05492721 — Phase 3
Contact Dermatitis Research Study Groups: Dermabond, Swiftset
Contact Dermatitis Clinical Trial 2023: 2-Octylcyanoacrylate Highlights & Side Effects. Trial Name: NCT05492721 — Phase 3
2-Octylcyanoacrylate (Tissue Adhesive) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05492721 — Phase 3
~31 spots leftby Jun 2025
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