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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
101
Cyanoacrylate glue for closure of surgical wounds
Cyanoacrylate glue for closure of surgical wounds
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Prisma Health
Greenville, South Carolina, United States
Prisma Health
Greenville, South Carolina, United States
Prisma Health
Greer, South Carolina, United States
Incidence of wound dehiscence
Proportion of subjects with evidence of partial or complete dehiscence assessed by the investigator
Time frame: 14 days post-surgery
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
Surgeon satisfaction with the device
To be assessed by the investigator using a Likert scale at the time of surgery
Time frame: 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.
Time frame: 14-days post-surgery
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