Comparing Tissue Adhesives in Port Site Closure

NCT05492721 | Completed Phase 3 Results FDA Device

• 1 other identifier: HSC-MS-22-0143
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Dermatitis, Contact

Keywords

GLUE; SURGICAL GLUE; DERMABOND; DERMATITIS

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Develop Contact Dermatitis

  Contact Dermatitis is defined as erythema or rash around incisions

  6 weeks

Secondary Outcomes (3)

• Mean Diameter of Erythema

  6 weeks

• Number of Participants With Wound Dehiscence

  6 weeks

• Number of Participants With Surgical Site Infection

  6 weeks

Study Arms (3)

Dermabond (2-Octylcyanoacrylate)

ACTIVE COMPARATOR

Dermabond over incisions

Device: Dermabond (2-Octylcyanoacrylate)

Swiftset (N-butyl-2-cyanoacrylate)

ACTIVE COMPARATOR

Swiftset over incisions

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

Liquiband (2-Octylcyanoacrylate)

ACTIVE COMPARATOR

Liquiband over incisions

Device: Liquiband (2-Octylcyanoacrylate)

Interventions

Swiftset (N-butyl-2-cyanoacrylate) DEVICE

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

Swiftset (N-butyl-2-cyanoacrylate)

Liquiband (2-Octylcyanoacrylate) DEVICE

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

Liquiband (2-Octylcyanoacrylate)

Dermabond (2-Octylcyanoacrylate) DEVICE

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

Dermabond (2-Octylcyanoacrylate)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

Memorial Hermann

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Dermatitis, Contact; Dermatitis

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Results Point of Contact

• Title: Julie Holihan, MD
• Organization: The University of Texas Health Science Center at Houston

julie.l.holihan@uth.tmc.edu

7135007245

Publication Agreements

• PI is Sponsor Employee: Yes

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
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Model Details: Each subject will have both glue types and serve as their own control

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: June 26, 2026
• Results First Posted: May 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)