Back to resultsLiquiBand® Exceed™ and LiquiBand® Rapid™ for General Surgery Procedures (Exceed)
Primary Purpose
Surgical Wound
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LiquiBand Exceed
LiquiBand Rapid
Sponsored by
About this trial
This is an interventional other trial for Surgical Wound focused on measuring Topical Skin Adhesives,, Cyanoacrylate, LiquiBand Exceed, Wound Closure, LiquiBand Rapid
Eligibility Criteria
Inclusion Criteria:
Patients who meet all of these criteria at time of enrollment may be included in the investigation:
- Subject is ≥ 18 years of age
- Subject is to undergo general abdominal surgery
- Planned incision(s) are expected to be 4cm or greater in length
- Subject is willing and able to comply with the protocol and follow up period
- Subject is willing and able to give written informed consent
Exclusion Criteria:
Patients who meet any one of these criteria will be excluded from the study:
- Subject is pregnant or nursing
- Subject has inadequate or unsuitable tissue e.g. due to radiation damage, ulceration compromised vascularity, history of compromised wound heal.
- Subject has a sensitivity to cyanoacrylates or formaldehyde
- Subject has a known sensitivity to topical skin adhesives
- Subject has active or potential infection at the surgical site
- Subject has a history of keloid formation
- Subject has a known vitamin C or zinc deficiency
- Subject has a connective tissue disorder
- Subject has uncontrolled diabetes mellitus
Sites / Locations
- The Ohio State University Wexner Medical CenterRecruiting
- Prisma HealthRecruiting
- Prisma Health
- Prisma Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
LiquiBand Exceed
Liquiband Rapid
Arm Description
Surgical wound closure using the LiquiBand Exceed Topical Skin Adhesive
Surgical wound closure using the LiquiBand Rapid Topical Skin Adhesive
Outcomes
Primary Outcome Measures
Incidence of wound dehiscence
Proportion of subjects with evidence of partial or complete dehiscence assessed by the investigator
Secondary Outcome Measures
Safety of Liquiband Exceed, assessed by incidence of device-related AEs / SAEs
Proportion of subjects who experience at least one device-related AE/SAE
Surgeon satisfaction with the device
To be assessed by the investigator using a Likert scale at the time of surgery
Cosmetic outcome
Investigator assessment of wound cosmesis using the Modified Hollander Wound Evaluation Scale (HWES).
This will be modified to a 6-point scale with one point assigned to any of the following observed wound appearances: step-off borders, contour irregularities, margin separation, edge inversion, excessive distortion, and overall appearance of wound. A HWES of 0 will indicate an optimal wound appearamce, with each point between 1 and 6 indicating a less adequate appearance of the wound.
Full Information
NCT ID
NCT04740775
First Posted
February 2, 2021
Last Updated
September 4, 2023
Sponsor
Advanced Medical Solutions Ltd.
Collaborators
BioStat International, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04740775
Brief Title
LiquiBand® Exceed™ and LiquiBand® Rapid™ for General Surgery Procedures
Acronym
Exceed
Official Title
Clinical Study to Evaluate LiquiBand® Exceed™ and LiquiBand® Rapid™ for Closure of Surgical Incisions Associated With Abdominal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 8, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Advanced Medical Solutions Ltd.
Collaborators
BioStat International, Inc.
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
The purpose of this post market study is to evaluate the performance and safety of LiquiBand® Exceed™ and LiquiBand® Rapid™ for closure of surgical incisions associated with abdominal surgery.
Detailed Description
LiquiBand® Exceed™ and LiquiBand® Rapid™ are the "study" devices. The study devices are an adhesive used to close surgical wounds. When the adhesive is applied to the skin, it polymerizes (forms a chemical bond) within minutes due to the moisture on the skin's surface and allows the wound edges to remain in the correct position. The use of the study devices are not "investigational" (experimental) because it is already cleared for doctors to use for surgical wound closure in the United States of America.
In this study, LiquiBand® Exceed™ and LiquiBand® Rapid™ will be used to close surgical wounds following general abdominal surgery. Subjects will be followed up for 14-days post surgery, and safety and performance of the study device will be evaluated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound
Keywords
Topical Skin Adhesives,, Cyanoacrylate, LiquiBand Exceed, Wound Closure, LiquiBand Rapid
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2-arm, non-comparative, open-label, prospective study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LiquiBand Exceed
Arm Type
Experimental
Arm Description
Surgical wound closure using the LiquiBand Exceed Topical Skin Adhesive
Arm Title
Liquiband Rapid
Arm Type
Experimental
Arm Description
Surgical wound closure using the LiquiBand Rapid Topical Skin Adhesive
Intervention Type
Device
Intervention Name(s)
LiquiBand Exceed
Intervention Description
Cyanoacrylate glue for closure of surgical wounds
Intervention Type
Device
Intervention Name(s)
LiquiBand Rapid
Intervention Description
Cyanoacrylate glue for closure of surgical wounds
Primary Outcome Measure Information:
Title
Incidence of wound dehiscence
Description
Proportion of subjects with evidence of partial or complete dehiscence assessed by the investigator
Time Frame
14 days post-surgery
Secondary Outcome Measure Information:
Title
Safety of Liquiband Exceed, assessed by incidence of device-related AEs / SAEs
Description
Proportion of subjects who experience at least one device-related AE/SAE
Time Frame
14-days post-surgery
Title
Surgeon satisfaction with the device
Description
To be assessed by the investigator using a Likert scale at the time of surgery
Time Frame
Day 0
Title
Cosmetic outcome
Description
Investigator assessment of wound cosmesis using the Modified Hollander Wound Evaluation Scale (HWES).
This will be modified to a 6-point scale with one point assigned to any of the following observed wound appearances: step-off borders, contour irregularities, margin separation, edge inversion, excessive distortion, and overall appearance of wound. A HWES of 0 will indicate an optimal wound appearamce, with each point between 1 and 6 indicating a less adequate appearance of the wound.
Time Frame
14-days post-surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who meet all of these criteria at time of enrollment may be included in the investigation:
Subject is ≥ 18 years of age
Subject is to undergo general abdominal surgery
Planned incision(s) are expected to be 4cm or greater in length
Subject is willing and able to comply with the protocol and follow up period
Subject is willing and able to give written informed consent
Exclusion Criteria:
Patients who meet any one of these criteria will be excluded from the study:
Subject is pregnant or nursing
Subject has inadequate or unsuitable tissue e.g. due to radiation damage, ulceration compromised vascularity, history of compromised wound heal.
Subject has a sensitivity to cyanoacrylates or formaldehyde
Subject has a known sensitivity to topical skin adhesives
Subject has active or potential infection at the surgical site
Subject has a history of keloid formation
Subject has a known vitamin C or zinc deficiency
Subject has a connective tissue disorder
Subject has uncontrolled diabetes mellitus
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tina Warburton
Phone
01606 863500
Email
tina.warburton@admedsol.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca Forder
Phone
01606 863500
Email
rebecca.forder@admedsol.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alfredo Carbonnell, MD
Organizational Affiliation
Prisma Health-Upstate
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
V Narula, MD
Phone
614-293-8000
First Name & Middle Initial & Last Name & Degree
Narula
First Name & Middle Initial & Last Name & Degree
Poulose
Facility Name
Prisma Health
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carbonell
First Name & Middle Initial & Last Name & Degree
Carbonell
First Name & Middle Initial & Last Name & Degree
Warren
First Name & Middle Initial & Last Name & Degree
Love
First Name & Middle Initial & Last Name & Degree
Wiese
Facility Name
Prisma Health
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Prisma Health
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Individual Site Status
Not yet recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
LiquiBand® Exceed™ and LiquiBand® Rapid™ for General Surgery Procedures
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