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Completed

NCT Number: NCT04740775

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University Wexner Medical Center, Columbus, Ohio, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LiquiBand Exceed

Device

Cyanoacrylate glue for closure of surgical wounds

LiquiBand Rapid

Device

Cyanoacrylate glue for closure of surgical wounds

Primary outcomes

  1. Incidence of wound dehiscence

    Time frame: 14 days post-surgery

    Proportion of subjects with evidence of partial or complete dehiscence assessed by the investigator

Secondary outcomes

  1. Safety of Liquiband Exceed, assessed by incidence of device-related AEs / SAEs

    Time frame: 14-days post-surgery

    Proportion of subjects who experience at least one device-related AE/SAE

  2. Surgeon satisfaction with the device

    Time frame: Day 0

    To be assessed by the investigator using a Likert scale at the time of surgery

  3. Cosmetic outcome

    Time frame: 14-days post-surgery

    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.

Sponsors and collaborators

Lead sponsor

Advanced Medical Solutions Ltd.

Industry

Collaborators

  • BioStat International, Inc.

Registry information

Official study title

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

Acronym: Exceed

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 5, 2021
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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