LiquiBand Exceed
DeviceCyanoacrylate glue for closure of surgical wounds
NCT Number: NCT04740775
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
The Ohio State University Wexner Medical Center, Columbus, Ohio, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients who meet all of these criteria at time of enrollment may be included in the investigation:
Exclusion criteria
Patients who meet any one of these criteria will be excluded from the study:
Cyanoacrylate glue for closure of surgical wounds
Cyanoacrylate glue for closure of surgical wounds
Time frame: 14 days post-surgery
Proportion of subjects with evidence of partial or complete dehiscence assessed by the investigator
Time frame: 14-days post-surgery
Proportion of subjects who experience at least one device-related AE/SAE
Time frame: Day 0
To be assessed by the investigator using a Likert scale at the time of surgery
Time frame: 14-days post-surgery
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.
Advanced Medical Solutions Ltd.
Industry
Clinical Study to Evaluate LiquiBand® Exceed™ and LiquiBand® Rapid™ for Closure of Surgical Incisions Associated With Abdominal Surgery
Acronym: Exceed
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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