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CompletedNCT04740775ExceedUpdated Jan 28, 2025

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

An interventional study of LiquiBand Exceed and LiquiBand Rapid in Surgical Wound, sponsored by Advanced Medical Solutions Ltd.. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-28.

Sponsored by Advanced Medical Solutions Ltd. · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was Mar 2024, 2 years 6 months ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
101
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Surgical Wound

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Keywords

  • Topical Skin Adhesives,
  • Cyanoacrylate
  • LiquiBand Exceed
  • Wound Closure
  • LiquiBand Rapid
03

In context

Surgical Wound

519 studies on the registry are indexed under Surgical Wound; 71 are open to participants now.

This study's enrollment of 101 is above the median of 80 across 412 interventional studies indexed under Surgical Wound.

Browse Surgical Wound studies →

Lead sponsor

Advanced Medical Solutions Ltd. is the lead sponsor of 14 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
101 participants (actual)

Study arms

  • Experimental
    LiquiBand Exceed

    Surgical wound closure using the LiquiBand Exceed Topical Skin Adhesive

    Device: LiquiBand Exceed

  • Experimental
    Liquiband Rapid

    Surgical wound closure using the LiquiBand Rapid Topical Skin Adhesive

    Device: LiquiBand Rapid

Interventions

  • DeviceLiquiBand Exceed

    Cyanoacrylate glue for closure of surgical wounds

  • DeviceLiquiBand Rapid

    Cyanoacrylate glue for closure of surgical wounds

06

What researchers measure

Primary outcomes

  1. Incidence of wound dehiscence

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

    Time frame: 14 days post-surgery

Secondary outcomes

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

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

    Time frame: 14-days post-surgery

  2. Surgeon satisfaction with the device

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

    Time frame: Day 0

  3. 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.

    Time frame: 14-days post-surgery

07

Study locations

4 sites
  • The Ohio State University Wexner Medical Center
    Columbus, Ohio 43210, United States
  • Prisma Health
    Greenville, South Carolina 29605, United States
  • Prisma Health
    Greenville, South Carolina 29607, United States
  • Prisma Health
    Greer, South Carolina 29650, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04740775
Lead sponsor
Advanced Medical Solutions Ltd.
Collaborators
BioStat International, Inc.
Responsible party
Sponsor
First posted
Feb 5, 2021
Start date
Nov 8, 2022
Primary completion
Mar 19, 2024
Completion
Sep 30, 2024
Last update
Jan 28, 2025

Study contacts

Alfredo Carbonnell, MD
principal investigator · Prisma Health-Upstate

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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