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Clinical Trial of MedLogic LiquiBand Laparoscopic Versus Dermabond in the Closure of Surgical Incisions

NCT00762905 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 460

Last updated 2010-01-12

No results posted yet for this study

Summary

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.

Conditions

  • Laparoscopic Surgery

Interventions

DEVICE

LiquiBand Laparoscopic

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.

DEVICE

Dermabond

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.

Sponsors & Collaborators

  • MedLogic Global Limited

    lead INDUSTRY

Principal Investigators

  • Richard Stenton · Sponsor Name Pending

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00762905 on ClinicalTrials.gov