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To evaluate the effectiveness, safety, and utility of LiquiBand Laparoscopic™ in relation to a currently approved active control product (High Viscosity DermaBond). Specifically, the study is powered to demonstrate that LiquiBand Laparoscopic™ is not inferior to DermaBond in the rates of infection, dehiscence, cosmesis and apposition of the skin.
This is a prospective, randomized, controlled, double-masked multi-center clinical trial. Patients requiring laparoscopic surgery will be enrolled and randomized to receive either LiquiBand Laparoscopic™ or DermaBond High Viscosity for incision closure. No other closure methods will be allowed. All eligible laparoscopic incisions per patient will be enrolled. Patients will be followed at 2 weeks and 3 months post-procedure to assess wound characteristics, wound infection, wound dehiscence and at 3 months for cosmesis. The study will be double-masked in that both the wound evaluator and patient will be masked to the randomized study treatment assignment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | LiquiBand Laparoscopic |
|
| 2 | Active Comparator | Dermabond |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LiquiBand Laparoscopic | Device | LiquiBand Laparoscopic™ is a sterile, liquid adhesive made up of a blend of n-butyl and 2-octyl cyanoacrylate intended for soft tissue approximation of skin wounds. It is packaged in a sterile, single-use, nylon applicator with internal glass ampoule containing 0.8g of adhesive and sealed in a PETG/Tyvek blister pack. LiquiBand Laparoscopic™ is intended to be applied topically to pre-apposed wound edges. The tissue adhesive sets rapidly (5 - 10 seconds) to hold the wound closed. Following wound closure the product is designed to apply a broad coverage of adhesive to act as a liquid dressing to protect the wound. |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of complete dermal apposition at 2-weeks (3 days) To compare the rates of wound infections and wound dehiscence The rate of optimal cosmesis (score=6) at 3-months (± 5 days) will be calculated | 8 to 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to close incision Patient and user satisfaction | 8 to 10 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Stenton | Sponsor Name Pending | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Milton Keynes General Hospital | Milton Keynes | Bucks | MK6 5LD | United Kingdom | ||
| Royal Devon and Exeter Hospital (Wonford |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24128996 | Derived | Kent A, Liversedge N, Dobbins B, McWhinnie D, Jan H. A prospective, randomized, controlled, double-masked, multi-center clinical trial of medical adhesives for the closure of laparoscopic incisions. J Minim Invasive Gynecol. 2014 Mar-Apr;21(2):252-8. doi: 10.1016/j.jmig.2013.10.003. Epub 2013 Oct 12. |
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| Dermabond | Device | High viscosity DermaBond Topical Skin Adhesive is a sterile, liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D & C Violet #2. It is provided in a single use applicator packaged in a blister pouch. The applicator is comprised of a crushable glass ampule contained within a plastic vial with attached applicator tip. As applied to skin, the liquid is syrup-like in viscosity and polymerizes within minutes. |
|
| Exeter |
| Devon |
| EX2 5DW |
| United Kingdom |
| Royal Surrey County Hospital | Guildford | Surrey | GU2 7XX | United Kingdom |
| Huddesfield Royal Infirmary | Huddersfield | West Yorkshire | HD3 3FA | United Kingdom |