Clinical trial NCT04740775: LiquiBand® Exceed™ and LiquiBand® Rapid™ for General Surgery Procedures
Official title: Clinical Study to Evaluate LiquiBand® Exceed™ and LiquiBand® Rapid™ for Closure of Surgical Incisions Associated With Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Wound
Keywords: Topical Skin Adhesives,
Cyanoacrylate
LiquiBand Exceed
Wound Closure
LiquiBand Rapid
Lead sponsor: Advanced Medical Solutions Ltd.
Sponsor class: INDUSTRY
Collaborators: name: BioStat International, Inc.
First posted: 2021-02-05
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2-arm, non-comparative, open-label, prospective study
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of wound dehiscence
timeFrame: 14 days post-surgery
Secondary outcomes:
measure: Safety of Liquiband Exceed, assessed by incidence of device-related AEs / SAEs
timeFrame: 14-days post-surgery
measure: Surgeon satisfaction with the device
timeFrame: Day 0
measure: Cosmetic outcome
timeFrame: 14-days post-surgery
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Greenville
country: United States
facility: Prisma Health
state: South Carolina
city: Greenville
country: United States
facility: Prisma Health
state: South Carolina
city: Greer
country: United States
facility: Prisma Health
state: South Carolina
Study officials:
affiliation: Prisma Health-Upstate
name: Alfredo Carbonnell, MD
role: PRINCIPAL_INVESTIGATOR
References: