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

Launched by ADVANCED MEDICAL SOLUTIONS LTD. · Feb 2, 2021

Keywords

ClinConnect Summary

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...

Gender

ALL

Eligibility criteria

• 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