Clinical trial NCT05492721: Comparing Tissue Adhesives in Port Site Closure
Official title: Comparing Tissue Adhesives in Port Site Closure: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Dermatitis, Contact
Keywords: GLUE
SURGICAL GLUE
DERMABOND
DERMATITIS
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2022-08-08
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each subject will have both glue types and serve as their own control
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: proportion of patients who develop contact dermatitis
timeFrame: 6 weeks
Secondary outcomes:
measure: mean diameter of erythema
timeFrame: 6 weeks
measure: proportion of patients with wound dehiscence
timeFrame: 6 weeks
measure: proportion of patients with surgical site infection
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: Memorial Hermann
state: Texas
Study officials:
References: