NCT04740775

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2021

Completed
1.8 years until next milestone

Study Start

First participant enrolled

November 8, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

January 28, 2025

Status Verified

December 1, 2024

Enrollment Period

1.4 years

First QC Date

February 2, 2021

Last Update Submit

January 27, 2025

Conditions

Surgical Wound

Keywords

Topical Skin Adhesives,CyanoacrylateLiquiBand ExceedWound ClosureLiquiBand Rapid

Outcome Measures

Primary Outcomes (1)

  • Incidence of wound dehiscence

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

    14 days post-surgery

Secondary Outcomes (3)

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

    14-days post-surgery

  • Surgeon satisfaction with the device

    Day 0

  • Cosmetic outcome

    14-days post-surgery

Study Arms (2)

LiquiBand Exceed

EXPERIMENTAL

Surgical wound closure using the LiquiBand Exceed Topical Skin Adhesive

Device: LiquiBand Exceed

Liquiband Rapid

EXPERIMENTAL

Surgical wound closure using the LiquiBand Rapid Topical Skin Adhesive

Device: LiquiBand Rapid

Interventions

LiquiBand ExceedDEVICE

Cyanoacrylate glue for closure of surgical wounds

LiquiBand Exceed
LiquiBand RapidDEVICE

Cyanoacrylate glue for closure of surgical wounds

Liquiband Rapid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Prisma Health

Greenville, South Carolina, 29605, United States

Location

Prisma Health

Greenville, South Carolina, 29607, United States

Location

Prisma Health

Greer, South Carolina, 29650, United States

Location

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Alfredo Carbonnell, MD

    Prisma Health-Upstate

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 2-arm, non-comparative, open-label, prospective study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2021

First Posted

February 5, 2021

Study Start

November 8, 2022

Primary Completion

March 19, 2024

Study Completion

September 30, 2024

Last Updated

January 28, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

US(4)