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Comparing Tissue Adhesives in Port Site Closure

Primary Purpose

Dermatitis, Contact

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
2-Octylcyanoacrylate
N-butyl-2-cyanoacrylate
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatitis, Contact focused on measuring GLUE, SURGICAL GLUE, DERMABOND, DERMATITIS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Memorial HermannRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Dermabond

Swiftset

Arm Description

Dermabond over incisions

Swiftset over incisions

Outcomes

Primary Outcome Measures

proportion of patients who develop contact dermatitis
erythema or rash around incisions

Secondary Outcome Measures

mean diameter of erythema
mean diameter of erythema around incisions for those with contact dermatitis
proportion of patients with wound dehiscence
opening of incisions
proportion of patients with surgical site infection
CDC definition of surgical site infection

Full Information

First Posted
August 5, 2022
Last Updated
August 8, 2023
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT05492721
Brief Title
Comparing Tissue Adhesives in Port Site Closure
Official Title
Comparing Tissue Adhesives in Port Site Closure: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 29, 2022 (Actual)
Primary Completion Date
June 29, 2024 (Anticipated)
Study Completion Date
October 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Contact
Keywords
GLUE, SURGICAL GLUE, DERMABOND, DERMATITIS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Each subject will have both glue types and serve as their own control
Masking
Outcomes Assessor
Masking Description
Outcome assessor does not know which glue was used
Allocation
Randomized
Enrollment
184 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dermabond
Arm Type
Active Comparator
Arm Description
Dermabond over incisions
Arm Title
Swiftset
Arm Type
Active Comparator
Arm Description
Swiftset over incisions
Intervention Type
Device
Intervention Name(s)
2-Octylcyanoacrylate
Other Intervention Name(s)
Dermabond
Intervention Description
Incisions on left will have one glue and on right will have the other glue
Intervention Type
Device
Intervention Name(s)
N-butyl-2-cyanoacrylate
Other Intervention Name(s)
Swiftset
Intervention Description
Incisions on left will have one glue and on right will have the other glue
Primary Outcome Measure Information:
Title
proportion of patients who develop contact dermatitis
Description
erythema or rash around incisions
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
mean diameter of erythema
Description
mean diameter of erythema around incisions for those with contact dermatitis
Time Frame
6 weeks
Title
proportion of patients with wound dehiscence
Description
opening of incisions
Time Frame
6 weeks
Title
proportion of patients with surgical site infection
Description
CDC definition of surgical site infection
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Holihan
Phone
7135007245
Email
julie.l.holihan@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Angielyn Rivera
Phone
+1 (713) 486-1350
Email
angielyn.r.rivera@uth.tmc.edu
Facility Information:
Facility Name
Memorial Hermann
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angielyn Rivera
Phone
713-486-1350
Email
angielyn.r.rivera@uth.tmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparing Tissue Adhesives in Port Site Closure

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