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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

Study 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.Check my eligibility

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.See study design

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

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I am scheduled for a minimally invasive abdominal surgery.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

proportion of patients who develop contact dermatitis

Secondary outcome measures

mean diameter of erythema

proportion of patients with surgical site infection

proportion of patients with wound dehiscence

Trial Design

2Treatment groups

Active Control

Group I: DermabondActive Control2 Interventions

Dermabond over incisions

Group II: SwiftsetActive Control2 Interventions

Swiftset over incisions

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor

904 Previous Clinical Trials

320,776 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does Swiftset meet the criteria for safety and efficacy set by the FDA?

"There is some evidence from earlier phases that Swiftset is effective, as well as data from multiple rounds of testing that support its safety--our team rates it a 3."

Answered by AI

Are we still able to enroll new participants for this clinical study?

"This medical trial is currently looking for patients to enroll. According to the information on clinicaltrials.gov, the trial was originally posted on June 29th, 2022 and was last updated on August 11th, 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparing Tissue Adhesives in Port Site Closure

Julie Holihan 2022. "Comparing Tissue Adhesives in Port Site Closure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05492721.

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