Comparing Tissue Adhesives in Port Site Closure
Comparing Tissue Adhesives in Port Site Closure: A Randomized Controlled Trial
Study Overview
Status
Conditions
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
- 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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Memorial Hermann
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Dermabond (2-Octylcyanoacrylate)
Dermabond over incisions
|
Incisions on left will have one glue and on right will have the other glue
|
|
Active Comparator: Swiftset (N-butyl-2-cyanoacrylate)
Swiftset over incisions
|
Incisions on left will have one glue and on right will have the other glue
|
|
Active Comparator: Liquiband (2-Octylcyanoacrylate)
Liquiband over incisions
|
Incisions on left will have one glue and on right will have the other glue
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants Who Develop Contact Dermatitis
Time Frame: 6 weeks
|
Contact Dermatitis is defined as erythema or rash around incisions
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Diameter of Erythema
Time Frame: 6 weeks
|
mean diameter of erythema around incisions for those with contact dermatitis
|
6 weeks
|
|
Number of Participants With Wound Dehiscence
Time Frame: 6 weeks
|
6 weeks
|
|
|
Number of Participants With Surgical Site Infection
Time Frame: 6 weeks
|
6 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC-MS-22-0143
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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