LiquiBand Versus Dermabond Versus Sutures for Closure of Surgical Wounds

Study Overview
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Brief Summary
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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.

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

Conditions
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Surgical Incisions

Intervention / Treatment
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* Device: LiquiBand Flex
* Device: Dermabond Advanced
* Device: Sutures (Prolene)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LiquiBand Flex<br>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<br> <br> |
| Active Comparator: Dermabond Advanced<br>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<br> <br> |
| Active Comparator: Sutures (Prolene)<br>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)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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