Comparing Tissue Adhesives in Port Site Closure
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- STATUS
- Recruiting
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- End date
- Oct 29, 2024
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- participants needed
- 184
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- sponsor
- The University of Texas Health Science Center, Houston
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.
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.
Details
| Condition | Dermatitis, Contact |
|---|---|
| Treatment | N-butyl-2-cyanoacrylate, 2-Octylcyanoacrylate (Dermabond), 2-Octylcyanoacrylate |
| Clinical Study Identifier | NCT05492721 |
| Sponsor | The University of Texas Health Science Center, Houston |
| Last Modified on | 20 August 2023 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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