LiquiBand Versus Dermabond Versus Sutures for Closure of Surgical Wounds

January 23, 2017 updated by: Advanced Medical Solutions Ltd.

A Prospective, Single-centre Study to Compare the Use of LiquiBand® Flex, Dermabond Advanced™ or Conventional Sutures for the Topical Closure of Surgical Wounds

To evaluate the cosmetic outcome, effectiveness, user and subject satisfaction, and safety of LiquiBand® Flex in relation to DermaBond Advanced™ and conventional sutures for the topical closure of surgical wounds.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Beverly, Massachusetts, United States, 01915
        • Oncology Care Center, Beverly Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or Female aged 18 or older on day of enrollment
  • Scheduled for surgical procedure by a delegated study surgeon
  • Fresh surgical wound with evenly distributed tension over length of incision
  • Willing and able to sign informed consent
  • Agree to return for 2 week (+/- 7 days) and 3 month (90 days +/- 7 days) post-procedure follow-up visit

Exclusion Criteria:

  • Known sensitivity to cyanoacrylates, formaldehyde or acetone products
  • Wounds in which incision edges are under high tension or not easily apposed (after deep layer suture), or over joints (unless immobilized)
  • Wounds less than 15mm in length
  • Wounds in which haemostasis is not able to be achieved, eg, drain is placed or Warfarin level >2.5 prior to surgery
  • Wounds in which deep closure could not be achieved
  • Surgical procedures involving mucus membranes or eyes
  • Mental incapacity, dementia, or inability to give informed consent
  • Pregnant or nursing
  • Disease related or pharmacologically immuno-compromised

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: LiquiBand Flex
LiquiBand® Flex skin adhesive is indicated for topical application only, to hold closed easily approximated skin edges from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed trauma-induced lacerations. It may be used in conjunction with, but not in place of deep dermal sutures.
Device: LiquiBand Flex
Active Comparator: Dermabond Advanced
Dermabond Advanced™ adhesive is intended for topical application only, to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. Dermabond Advanced ™ adhesive may be used in conjunction with, but not in place of, deep dermal stitches.
Device: Dermabond Advanced
Active Comparator: Sutures (Prolene)
Prolene™ Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Device: Sutures (Prolene)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare cosmetic outcomes at follow up
Time Frame: 3 months post treatment
Cosmesis to be evaluated by a panel of masked evaluators using a modified Hollander Wound Evaluation Scale
3 months post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Advanced Medical Solutions Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2013

Primary Completion (Actual)

February 14, 2014

Study Completion (Actual)

February 14, 2014

Study Registration Dates

First Submitted

April 12, 2013

First Submitted That Met QC Criteria

April 18, 2013

First Posted (Estimate)

April 19, 2013

Study Record Updates

Last Update Posted (Estimate)

January 24, 2017

Last Update Submitted That Met QC Criteria

January 23, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D-LBF001-05-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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