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

Study Overview
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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.

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.

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

Conditions
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Surgical Wound

Intervention / Treatment
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* Device: LiquiBand Exceed
* Device: LiquiBand Rapid


Participation Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2-arm, non-comparative, open-label, prospective study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LiquiBand Exceed<br>Surgical wound closure using the LiquiBand Exceed Topical Skin Adhesive | Device: LiquiBand Exceed<br>* Cyanoacrylate glue for closure of surgical wounds<br>|
| Experimental: Liquiband Rapid<br>Surgical wound closure using the LiquiBand Rapid Topical Skin Adhesive | Device: LiquiBand Rapid<br>* Cyanoacrylate glue for closure of surgical wounds<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of wound dehiscence | Proportion of subjects with evidence of partial or complete dehiscence assessed by the investigator | 14 days post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Liquiband Exceed, assessed by incidence of device-related AEs / SAEs | Proportion of subjects who experience at least one device-related AE/SAE | 14-days post-surgery | 
| Surgeon satisfaction with the device | To be assessed by the investigator using a Likert scale at the time of surgery | Day 0 | 
| 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. | 14-days post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Topical Skin Adhesives,, Cyanoacrylate, LiquiBand Exceed, Wound Closure, LiquiBand Rapid