Comparing Tissue Adhesives in Port Site Closure

Sponsor
The University of Texas Health Science Center, Houston (Other)
Overall Status
Recruiting
CT.gov ID
NCT05492721
Collaborator
(none)
186
1
2
24
7.7

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
  • Device: 2-Octylcyanoacrylate
  • Device: N-butyl-2-cyanoacrylate
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

  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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
186 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Each subject will have both glue types and serve as their own controlEach subject will have both glue types and serve as their own control
Masking:
Single (Outcomes Assessor)
Masking Description:
Outcome assessor does not know which glue was used
Primary Purpose:
Treatment
Official Title:
Comparing Tissue Adhesives in Port Site Closure: A Randomized Controlled Trial
Actual Study Start Date :
Jun 29, 2022
Anticipated Primary Completion Date :
Jun 29, 2023
Anticipated Study Completion Date :
Jun 29, 2024

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:
  • Dermabond
  • 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:
  • Swiftset
  • Outcome Measures

    Primary Outcome Measures

    1. proportion of patients who develop contact dermatitis [6 weeks]

      erythema or rash around incisions

    Secondary Outcome Measures

    1. mean diameter of erythema [6 weeks]

      mean diameter of erythema around incisions for those with contact dermatitis

    2. proportion of patients with wound dehiscence [6 weeks]

      opening of incisions

    3. proportion of patients with surgical site infection [6 weeks]

      CDC definition of surgical site infection

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    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.
    Responsible Party:
    Julie Holihan, Assistant Professor of Surgery, The University of Texas Health Science Center, Houston
    ClinicalTrials.gov Identifier:
    NCT05492721
    Other Study ID Numbers:
    • HSC-MS-22-0143
    First Posted:
    Aug 8, 2022
    Last Update Posted:
    Aug 16, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Julie Holihan, Assistant Professor of Surgery, The University of Texas Health Science Center, Houston
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 16, 2022