LiquiBand® Exceed™ and LiquiBand® Rapid™ for General Surgery Procedures (Exceed)

Clinical Study to Evaluate LiquiBand® Exceed™ and LiquiBand® Rapid™ for Closure of Surgical Incisions Associated With Abdominal Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Surgical Wound
• Intervention / Treatment: Device: LiquiBand Exceed; Device: LiquiBand Rapid

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tina Warburton; Phone Number: 01606 863500; Email: tina.warburton@admedsol.com
• Study Contact Backup: Name: Rebecca Forder; Phone Number: 01606 863500; Email: rebecca.forder@admedsol.com

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University Wexner Medical Center
      • Contact: V Narula, MD; Phone Number: 614-293-8000
      • Principal Investigator: Narula
      • Sub-Investigator: Poulose
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Recruiting
      • Prisma Health
      • Contact: Carbonell
      • Principal Investigator: Carbonell
      • Principal Investigator: Warren
      • Sub-Investigator: Love
      • Sub-Investigator: Wiese
    • Greenville, South Carolina, United States, 29607
      • Not yet recruiting
      • Prisma Health
    • Greer, South Carolina, United States, 29650
      • Not yet recruiting
      • Prisma Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Patients who meet all of these criteria at time of enrollment may be included in the investigation:

1. Subject is ≥ 18 years of age
2. Subject is to undergo general abdominal surgery
3. Planned incision(s) are expected to be 4cm or greater in length
4. Subject is willing and able to comply with the protocol and follow up period
5. 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:

1. Subject is pregnant or nursing
2. Subject has inadequate or unsuitable tissue e.g. due to radiation damage, ulceration compromised vascularity, history of compromised wound heal.
3. Subject has a sensitivity to cyanoacrylates or formaldehyde
4. Subject has a known sensitivity to topical skin adhesives
5. Subject has active or potential infection at the surgical site
6. Subject has a history of keloid formation
7. Subject has a known vitamin C or zinc deficiency
8. Subject has a connective tissue disorder
9. Subject has uncontrolled diabetes mellitus

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LiquiBand Exceed; Surgical wound closure using the LiquiBand Exceed Topical Skin Adhesive	Device: LiquiBand Exceed; Cyanoacrylate glue for closure of surgical wounds
Experimental: Liquiband Rapid; Surgical wound closure using the LiquiBand Rapid Topical Skin Adhesive	Device: LiquiBand Rapid; Cyanoacrylate glue for closure of surgical wounds

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of wound dehiscence	Proportion of subjects with evidence of partial or complete dehiscence assessed by the investigator	14 days post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of Liquiband Exceed, assessed by incidence of device-related AEs / SAEs	Proportion of subjects who experience at least one device-related AE/SAE	14-days post-surgery
Surgeon satisfaction with the device	To be assessed by the investigator using a Likert scale at the time of surgery	Day 0
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.	14-days post-surgery

Collaborators and Investigators

• Sponsor: Advanced Medical Solutions Ltd.
• Collaborators: BioStat International, Inc.
• Investigators: Principal Investigator: Alfredo Carbonnell, MD, Prisma Health-Upstate

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2022
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: February 2, 2021
• First Submitted That Met QC Criteria: February 2, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Cyanoacrylate; Wound Closure; Topical Skin Adhesives,; LiquiBand Exceed; LiquiBand Rapid
• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: Exceed 01-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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