Comparing Tissue Adhesives in Port Site Closure
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
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Phase 3 |
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
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Patients unlikely to follow-up (live out of state, unable to be reached by phone or email)
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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 Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
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:
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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:
|
Outcome Measures
Primary Outcome Measures
- proportion of patients who develop contact dermatitis [6 weeks]
erythema or rash around incisions
Secondary Outcome Measures
- mean diameter of erythema [6 weeks]
mean diameter of erythema around incisions for those with contact dermatitis
- proportion of patients with wound dehiscence [6 weeks]
opening of incisions
- proportion of patients with surgical site infection [6 weeks]
CDC definition of surgical site infection
Eligibility Criteria
Criteria
Inclusion Criteria:
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18 or older
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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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Memorial Hermann | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- The University of Texas Health Science Center, Houston
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HSC-MS-22-0143