NCT05492721

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2022

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 29, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 5, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 8, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2025

Completed
Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

3 years

First QC Date

August 5, 2022

Last Update Submit

February 4, 2026

Conditions

Dermatitis, Contact

Keywords

GLUESURGICAL GLUEDERMABONDDERMATITIS

Outcome Measures

Primary Outcomes (1)

  • proportion of patients who develop contact dermatitis

    erythema or rash around incisions

    6 weeks

Secondary Outcomes (3)

  • mean diameter of erythema

    6 weeks

  • proportion of patients with wound dehiscence

    6 weeks

  • proportion of patients with surgical site infection

    6 weeks

Study Arms (2)

Dermabond

ACTIVE COMPARATOR

Dermabond over incisions

Device: 2-Octylcyanoacrylate

Swiftset

ACTIVE COMPARATOR

Swiftset over incisions

Device: N-butyl-2-cyanoacrylate

Interventions

2-OctylcyanoacrylateDEVICE

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

Also known as: Dermabond
Dermabond
N-butyl-2-cyanoacrylateDEVICE

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

Also known as: Swiftset
Swiftset

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Hermann

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Dermatitis, ContactDermatitis

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Eczematous

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessor does not know which glue was used
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Each subject will have both glue types and serve as their own control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Surgery

Study Record Dates

First Submitted

August 5, 2022

First Posted

August 8, 2022

Study Start

June 29, 2022

Primary Completion

June 23, 2025

Study Completion

June 23, 2025

Last Updated

February 9, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)