Status:
COMPLETED
LiquiBand® Exceed™ and LiquiBand® Rapid™ for General Surgery Procedures
Lead Sponsor:
Advanced Medical Solutions Ltd.
Collaborating Sponsors:
BioStat International, Inc.
Conditions:
Surgical Wound
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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
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 che...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT04740775
Start Date
November 8 2022
End Date
September 30 2024
Last Update
January 28 2025
Active Locations (4)
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1
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
2
Prisma Health
Greenville, South Carolina, United States, 29605
3
Prisma Health
Greenville, South Carolina, United States, 29607
4
Prisma Health
Greer, South Carolina, United States, 29650