Comparing Tissue Adhesives in Port Site Closure

Study Overview
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Brief Summary
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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
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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 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. 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.

Official Title
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Comparing Tissue Adhesives in Port Site Closure: A Randomized Controlled Trial

Conditions
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Dermatitis, Contact

Intervention / Treatment
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* Device: 2-Octylcyanoacrylate
* Device: N-butyl-2-cyanoacrylate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Each subject will have both glue types and serve as their own control
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GLUE, SURGICAL GLUE, DERMABOND, DERMATITIS