LiquiBand Versus Dermabond Versus Sutures for Closure of Surgical Wounds

NCT ID: NCT01835405

Last Updated: 2017-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-20

Study Completion Date

2014-02-14

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.

Detailed Description

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Conditions

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Surgical Incisions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

LiquiBand Flex

Intervention Type DEVICE

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.

Group Type ACTIVE_COMPARATOR

Dermabond Advanced

Intervention Type DEVICE

Sutures (Prolene)

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

Group Type ACTIVE_COMPARATOR

Sutures (Prolene)

Intervention Type DEVICE

Interventions

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LiquiBand Flex

Intervention Type DEVICE

Dermabond Advanced

Intervention Type DEVICE

Sutures (Prolene)

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Advanced Medical Solutions Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Oncology Care Center, Beverly Hospital

Beverly, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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D-LBF001-05-1

Identifier Type: -

Identifier Source: org_study_id

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