Comparing two types of surgical glue for closing port sites after surgery
Comparing Tissue Adhesives in Port Site Closure: A Randomized Controlled Trial
PHASE3 · The University of Texas Health Science Center, Houston · NCT05492721
This study is testing two types of surgical glue to see which one works better for closing small cuts after abdominal surgery and if either causes skin irritation.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 184 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston (other) |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05492721 on ClinicalTrials.gov |
What this trial studies
This multi-center randomized controlled trial evaluates the effectiveness of two surgical adhesives, 2-Octylcyanoacrylate and n-butyl-2-cyanoacrylate, in closing port sites after laparoscopic or robotic abdominal surgeries. Adult patients undergoing elective procedures will be enrolled and each will have both types of glue applied to different sides of their abdomen, with the assignment based on the day of the month. The primary outcome measured will be the incidence of contact dermatitis within six weeks post-operation, assessed by a blinded clinician.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older who are scheduled for elective laparoscopic or robotic abdominal surgery.
Not a fit: Patients with known allergies to the surgical adhesives being tested or those unlikely to follow up will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes and reduced incidence of dermatitis for patients undergoing laparoscopic or robotic surgeries.
How similar studies have performed: Previous studies have shown varying success with surgical adhesives, but this specific comparison of these two types is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Houston, Texas
- Memorial Hermann — Houston, Texas, United States (RECRUITING)
Study contacts
- Study coordinator: Julie Holihan
- Email: julie.l.holihan@uth.tmc.edu
- Phone: 7135007245
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dermatitis, Contact, GLUE, SURGICAL GLUE, DERMABOND, DERMATITIS