Comparing Tissue Adhesives in Port Site Closure: A Randomized Controlled Trial
Comparing Tissue Adhesives in Port Site Closure
Sponsors
Source
The University of Texas Health Science Center, Houston
Oversight Info
Has Dmc
No
Is Us Export
No
Is Fda Regulated Drug
No
Is Fda Regulated Device
Yes
Brief Summary
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
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.
Overall Status
Recruiting
Start Date
2022-06-29
Completion Date
2025-10-29
Primary Completion Date
2025-06-29
Phase
Phase 3
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
proportion of patients who develop contact dermatitis |
6 weeks |
Secondary Outcome
Measure |
Time Frame |
|
mean diameter of erythema |
6 weeks |
|
proportion of patients with wound dehiscence |
6 weeks |
|
proportion of patients with surgical site infection |
6 weeks |
Enrollment
184
Condition
Intervention
Intervention Type
Device
Intervention Name
Description
Incisions on left will have one glue and on right will have the other glue
Arm Group Label
Dermabond
Other Name
Dermabond
Intervention Type
Device
Intervention Name
Description
Incisions on left will have one glue and on right will have the other glue
Arm Group Label
Swiftset
Other Name
Swiftset
Eligibility
Criteria
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.
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Contact
Last Name
Julie Holihan
Phone
7135007245
julie.l.holihan@uth.tmc.edu
Location
Facility |
Status |
Contact |
|
Memorial Hermann Houston 4699066 Texas 4736286 77030 United States |
Recruiting |
Last Name: Angielyn Rivera Phone: 713-486-1350 Email: angielyn.r.rivera@uth.tmc.edu |
Location Countries
Country
United States
Verification Date
2024-12-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
The University of Texas Health Science Center, Houston
Investigator Full Name
Julie Holihan
Investigator Title
Assistant Professor of Surgery
Keywords
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Arm Group
Arm Group Label
Dermabond
Arm Group Type
Active Comparator
Description
Dermabond over incisions
Arm Group Label
Swiftset
Arm Group Type
Active Comparator
Description
Swiftset over incisions
Firstreceived Results Date
N/A
Overall Contact Backup
Last Name
Angielyn Rivera
Phone
+1 (713) 486-1350
angielyn.r.rivera@uth.tmc.edu
Patient Data
Sharing Ipd
No
Firstreceived Results Disposition Date
N/A
Study Design Info
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
Study First Submitted
August 5, 2022
Study First Submitted Qc
August 5, 2022
Study First Posted
August 8, 2022
Last Update Submitted
December 5, 2024
Last Update Submitted Qc
December 5, 2024
Last Update Posted
December 6, 2024
ClinicalTrials.gov processed this data on October 31, 2025
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.