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| Name | Class |
|---|---|
| BioStat International, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LiquiBand Exceed | Experimental | Surgical wound closure using the LiquiBand Exceed Topical Skin Adhesive |
|
| Liquiband Rapid | Experimental | Surgical wound closure using the LiquiBand Rapid Topical Skin Adhesive |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LiquiBand Exceed | Device | Cyanoacrylate glue for closure of surgical wounds |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of wound dehiscence | Proportion of subjects with evidence of partial or complete dehiscence assessed by the investigator | 14 days post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Liquiband Exceed, assessed by incidence of device-related AEs / SAEs | Proportion of subjects who experience at least one device-related AE/SAE | 14-days post-surgery |
| Surgeon satisfaction with the device |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Alfredo Carbonnell, MD | Prisma Health-Upstate | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States | ||
| Prisma Health |
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| ID | Term |
|---|---|
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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2-arm, non-comparative, open-label, prospective study
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| LiquiBand Rapid |
| Device |
Cyanoacrylate glue for closure of surgical wounds |
|
To be assessed by the investigator using a Likert scale at the time of surgery
| 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. | 14-days post-surgery |
| Greenville |
| South Carolina |
| 29605 |
| United States |
| Prisma Health | Greenville | South Carolina | 29607 | United States |
| Prisma Health | Greer | South Carolina | 29650 | United States |