Surgical Wound
Conditions
Keywords
Topical Skin Adhesives,, Cyanoacrylate, LiquiBand Exceed, Wound Closure, LiquiBand Rapid
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 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.
Interventions
DEVICELiquiBand Exceed
Cyanoacrylate glue for closure of surgical wounds
DEVICELiquiBand Rapid
Cyanoacrylate glue for closure of surgical wounds
Sponsors
BioStat International, Inc.
Advanced Medical Solutions Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
2-arm, non-comparative, open-label, prospective study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of wound dehiscence | 14 days post-surgery | Proportion of subjects with evidence of partial or complete dehiscence assessed by the investigator |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Liquiband Exceed, assessed by incidence of device-related AEs / SAEs | 14-days post-surgery | Proportion of subjects who experience at least one device-related AE/SAE |
| Surgeon satisfaction with the device | Day 0 | To be assessed by the investigator using a Likert scale at the time of surgery |
| Cosmetic outcome | 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. |
Countries
United States
Outcome results
None listed