Comparing Tissue Adhesives in Port Site Closure

The University of Texas System (UT)

Status and phase: Enrolling; Phase 3

Conditions: Dermatitis, Contact

Treatments: Device: N-butyl-2-cyanoacrylate; Device: 2-Octylcyanoacrylate

Study type: Interventional

Funder types: Other

Identifiers

NCT05492721

HSC-MS-22-0143

Details and patient eligibility

About

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.

Full 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.

Enrollment: 184 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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184 participants in 2 patient groups

Dermabond

Active Comparator group

Description:

Dermabond over incisions

Treatment:

Device: 2-Octylcyanoacrylate

Swiftset

Active Comparator group

Description:

Swiftset over incisions

Treatment:

Device: N-butyl-2-cyanoacrylate