Comparing Tissue Adhesives in Port Site Closure

Purpose

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.

Condition

  • Dermatitis, Contact

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Each subject will have both glue types and serve as their own control
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)
Masking Description
Outcome assessor does not know which glue was used

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Memorial Hermann
Houston, Texas 77030
Contact:
Angielyn Rivera
713-486-1350
angielyn.r.rivera@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Julie Holihan
7135007245
julie.l.holihan@uth.tmc.edu

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.