Comparing Tissue Adhesives in Port Site Closure

Dermatitis, Contact Clinical Trial

Official title:

Comparing Tissue Adhesives in Port Site Closure: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05492721
• Other study ID #: HSC-MS-22-0143
• Status: Recruiting
• Phase: Phase 3
• Start date: June 29, 2022
• Est. completion date: October 29, 2024

Study information

• Verified date: August 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: Julie Holihan
• Phone: 7135007245
• Email: julie.l.holihan[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 184
• Est. completion date: October 29, 2024
• Est. primary completion date: June 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Contact

Intervention

Device:
• 2-Octylcyanoacrylate
Incisions on left will have one glue and on right will have the other glue
• N-butyl-2-cyanoacrylate
Incisions on left will have one glue and on right will have the other glue

Locations

Country	Name	City	State
United States	Memorial Hermann	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of patients who develop contact dermatitis	erythema or rash around incisions	6 weeks
Secondary	mean diameter of erythema	mean diameter of erythema around incisions for those with contact dermatitis	6 weeks
Secondary	proportion of patients with wound dehiscence	opening of incisions	6 weeks
Secondary	proportion of patients with surgical site infection	CDC definition of surgical site infection	6 weeks