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Comparing Tissue Adhesives in Port Site Closure

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ClinicalTrials.gov Identifier: NCT05492721
Recruitment Status : Recruiting
First Posted : August 8, 2022
Last Update Posted : August 16, 2022
Sponsor:
Information provided by (Responsible Party):
Julie Holihan, The University of Texas Health Science Center, Houston

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
Dermatitis, Contact 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Each 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 : June 29, 2022
Estimated Primary Completion Date : June 29, 2023
Estimated Study Completion Date : June 29, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Dermabond

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 Name: 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 Name: Swiftset




Primary Outcome Measures :
  1. proportion of patients who develop contact dermatitis [ Time Frame: 6 weeks ]
    erythema or rash around incisions


Secondary Outcome Measures :
  1. mean diameter of erythema [ Time Frame: 6 weeks ]
    mean diameter of erythema around incisions for those with contact dermatitis

  2. proportion of patients with wound dehiscence [ Time Frame: 6 weeks ]
    opening of incisions

  3. proportion of patients with surgical site infection [ Time Frame: 6 weeks ]
    CDC definition of surgical site infection



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05492721


Contacts
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Contact: Julie Holihan 7135007245 julie.l.holihan@uth.tmc.edu
Contact: Angielyn Rivera +1 (713) 486-1350 angielyn.r.rivera@uth.tmc.edu

Locations
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United States, Texas
Memorial Hermann Recruiting
Houston, Texas, United States, 77030
Contact: Angielyn Rivera    713-486-1350    angielyn.r.rivera@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
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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: August 8, 2022    Key Record Dates
Last Update Posted: August 16, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, The University of Texas Health Science Center, Houston:
GLUE
SURGICAL GLUE
DERMABOND
DERMATITIS
Additional relevant MeSH terms:
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Dermatitis
Dermatitis, Contact
Skin Diseases
Skin Diseases, Eczematous