Comparing Tissue Adhesives in Port Site Closure

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.

Study Overview

• Status: Recruiting
• Conditions: Dermatitis, Contact
• Intervention / Treatment: Device: 2-Octylcyanoacrylate; Device: 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

1. Patients unlikely to follow-up (live out of state, unable to be reached by phone or email)
2. 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 Type: Interventional
• Enrollment (Estimated): 184
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Julie Holihan; Phone Number: 7135007245; Email: julie.l.holihan@uth.tmc.edu
• Study Contact Backup: Name: Angielyn Rivera; Phone Number: +1 (713) 486-1350; Email: angielyn.r.rivera@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Memorial Hermann
      • Contact: Angielyn Rivera; Phone Number: 713-486-1350; Email: angielyn.r.rivera@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dermabond; Dermabond over incisions	Device: 2-Octylcyanoacrylate; Incisions on left will have one glue and on right will have the other glue; Other Names: Dermabond
Active Comparator: Swiftset; Swiftset over incisions	Device: N-butyl-2-cyanoacrylate; Incisions on left will have one glue and on right will have the other glue; Other Names: Swiftset

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
proportion of patients who develop contact dermatitis	erythema or rash around incisions	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean diameter of erythema	mean diameter of erythema around incisions for those with contact dermatitis	6 weeks
proportion of patients with wound dehiscence	opening of incisions	6 weeks
proportion of patients with surgical site infection	CDC definition of surgical site infection	6 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2022
• Primary Completion (Estimated): June 29, 2024
• Study Completion (Estimated): October 29, 2024

Study Registration Dates

• First Submitted: August 5, 2022
• First Submitted That Met QC Criteria: August 5, 2022
• First Posted (Actual): August 8, 2022

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 8, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: DERMATITIS; GLUE; SURGICAL GLUE; DERMABOND
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Eczematous; Dermatitis; Dermatitis, Contact
• Other Study ID Numbers: HSC-MS-22-0143

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No