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LiquiBand Versus Dermabond Versus Sutures for Closure of Surgical Wounds

Primary Purpose

Surgical Incisions

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LiquiBand Flex
Dermabond Advanced
Sutures (Prolene)
Sponsored by
Advanced Medical Solutions Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgical Incisions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oncology Care Center, Beverly Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

LiquiBand Flex

Dermabond Advanced

Sutures (Prolene)

Arm Description

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.

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.

Prolene™ Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Outcomes

Primary Outcome Measures

To compare cosmetic outcomes at follow up
Cosmesis to be evaluated by a panel of masked evaluators using a modified Hollander Wound Evaluation Scale

Secondary Outcome Measures

Full Information

First Posted
April 12, 2013
Last Updated
January 23, 2017
Sponsor
Advanced Medical Solutions Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01835405
Brief Title
LiquiBand Versus Dermabond Versus Sutures for Closure of Surgical Wounds
Official Title
A Prospective, Single-centre Study to Compare the Use of LiquiBand® Flex, Dermabond Advanced™ or Conventional Sutures for the Topical Closure of Surgical Wounds
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
February 20, 2013 (Actual)
Primary Completion Date
February 14, 2014 (Actual)
Study Completion Date
February 14, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Advanced Medical Solutions Ltd.

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Incisions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LiquiBand Flex
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Dermabond Advanced
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sutures (Prolene)
Arm Type
Active Comparator
Arm Description
Prolene™ Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Intervention Type
Device
Intervention Name(s)
LiquiBand Flex
Intervention Type
Device
Intervention Name(s)
Dermabond Advanced
Intervention Type
Device
Intervention Name(s)
Sutures (Prolene)
Primary Outcome Measure Information:
Title
To compare cosmetic outcomes at follow up
Description
Cosmesis to be evaluated by a panel of masked evaluators using a modified Hollander Wound Evaluation Scale
Time Frame
3 months post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Oncology Care Center, Beverly Hospital
City
Beverly
State/Province
Massachusetts
ZIP/Postal Code
01915
Country
United States

12. IPD Sharing Statement

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LiquiBand Versus Dermabond Versus Sutures for Closure of Surgical Wounds

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