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

Surgical Wound Clinical Trial

— Exceed  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04740775
• Other study ID #: Exceed 01-2020
• Status: Recruiting
• Phase: N/A
• Start date: November 8, 2022
• Est. completion date: April 2024

Study information

• Verified date: September 2023
• Source: Advanced Medical Solutions Ltd.
• Contact: Tina Warburton
• Phone: 01606 863500
• Email: tina.warburton[@]admedsol.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgical Wound

Intervention

Device:
• LiquiBand Exceed
Cyanoacrylate glue for closure of surgical wounds
• LiquiBand Rapid
Cyanoacrylate glue for closure of surgical wounds

Locations

Country	Name	City	State
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Prisma Health	Greenville	South Carolina
United States	Prisma Health	Greenville	South Carolina
United States	Prisma Health	Greer	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Advanced Medical Solutions Ltd.	BioStat International, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of wound dehiscence	Proportion of subjects with evidence of partial or complete dehiscence assessed by the investigator	14 days post-surgery
Secondary	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
Secondary	Surgeon satisfaction with the device	To be assessed by the investigator using a Likert scale at the time of surgery	Day 0
Secondary	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