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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Dermabond |
Dermabond over incisions |
|
|
Active Comparator Swiftset |
Swiftset over incisions |
|
Recruiting Locations
Houston, Texas 77030
More Details
- Status
- Recruiting
- Sponsor
- The University of Texas Health Science Center, Houston
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.