Comparing Tissue Adhesives in Port Site Closure

Phase 3

Recruiting

• Conditions: Dermatitis, Contact
• Interventions: Device: 2-Octylcyanoacrylate; Device: N-butyl-2-cyanoacrylate

• Registration Number: NCT05492721
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

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 Timeline

• Study Start: 2022-06-29
• Study First Submitted: 2022-08-05
• Study First Submitted QC: 2022-08-05
• Study First Posted: 2022-08-08
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-06
• Primary Completion: 2025-06-29
• Study Completion: 2025-10-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 184

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dermabond	2-Octylcyanoacrylate	Dermabond over incisions
Swiftset	N-butyl-2-cyanoacrylate	Swiftset over incisions

Primary Outcome Measures

Name	Time	Method
proportion of patients who develop contact dermatitis	6 weeks	erythema or rash around incisions

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Memorial Hermann; 🇺🇸 Houston, Texas, United States