Tissue Adhesives for Surgical Port Closure
Trial Summary
What is the purpose of this trial?
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.
Do I need to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment 2-Octylcyanoacrylate (Dermabond) for surgical port closure?
Research shows that 2-Octylcyanoacrylate (Dermabond) is effective for closing surgical skin incisions, providing a strong barrier against microorganisms, and offering cosmetic results comparable to traditional methods. It has been successfully used in various procedures, including laparoscopic surgeries and circumcisions, with faster closure times and good cosmetic outcomes.12345
Is Dermabond (2-octyl cyanoacrylate) generally safe for use in humans?
How is the treatment 2-Octylcyanoacrylate different from other treatments for surgical port closure?
2-Octylcyanoacrylate (Dermabond) is unique because it acts as a tissue 'glue' that closes wounds without the need for stitches, reducing the risk of infection and providing a strong barrier against bacteria. It is easy to apply and offers cosmetic results that are as good as or better than traditional methods.134910
Eligibility Criteria
This trial is for adults over 18 who are scheduled for elective laparoscopic or robotic abdominal surgery. It's not suitable for those with allergies to the tissue adhesives being tested or individuals who may not be able to attend follow-up appointments, such as living out of state.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo elective laparoscopic or robotic abdominal surgery with application of surgical glues
Follow-up
Participants are monitored for contact dermatitis and other skin reactions post-surgery
Treatment Details
Interventions
- 2-Octylcyanoacrylate
- 2-Octylcyanoacrylate (Dermabond)
- N-butyl-2-cyanoacrylate
2-Octylcyanoacrylate is already approved in United States, Canada, European Union for the following indications:
- Closure of skin wounds with easily approximated edges
- Combination with subcuticular sutures for deeper or higher tension wounds
- Closure of skin wounds with easily approximated edges
- Combination with subcuticular sutures for deeper or higher tension wounds
- Closure of skin wounds with easily approximated edges
- Combination with subcuticular sutures for deeper or higher tension wounds
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Health Science Center, Houston
Lead Sponsor