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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-08

Study Completion Date

2024-09-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Surgical Wound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2-arm, non-comparative, open-label, prospective study

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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LiquiBand Exceed

Surgical wound closure using the LiquiBand Exceed Topical Skin Adhesive

Group Type EXPERIMENTAL

LiquiBand Exceed

Intervention Type DEVICE

Cyanoacrylate glue for closure of surgical wounds

Liquiband Rapid

Surgical wound closure using the LiquiBand Rapid Topical Skin Adhesive

Group Type EXPERIMENTAL

LiquiBand Rapid

Intervention Type DEVICE

Cyanoacrylate glue for closure of surgical wounds

Interventions

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LiquiBand Exceed

Cyanoacrylate glue for closure of surgical wounds

Intervention Type DEVICE

LiquiBand Rapid

Cyanoacrylate glue for closure of surgical wounds

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No