Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
184 participants
INTERVENTIONAL
2022-06-29
2025-10-29
Brief Summary
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Detailed Description
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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.
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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Dermabond
Dermabond over incisions
2-Octylcyanoacrylate
Incisions on left will have one glue and on right will have the other glue
Swiftset
Swiftset over incisions
N-butyl-2-cyanoacrylate
Incisions on left will have one glue and on right will have the other glue
Interventions
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2-Octylcyanoacrylate
Incisions on left will have one glue and on right will have the other glue
N-butyl-2-cyanoacrylate
Incisions on left will have one glue and on right will have the other glue
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* undergoing an elective laparoscopic or robotic abdominal surgery
Exclusion Criteria
* Patients with a known allergy to 2-Octylcyanoacrylate or N-butyl-2-cyanoacrylate.
18 Years
ALL
No
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Julie Holihan
Assistant Professor of Surgery
Locations
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Memorial Hermann
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Angielyn Rivera
Role: primary
Other Identifiers
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HSC-MS-22-0143
Identifier Type: -
Identifier Source: org_study_id