Octylseal Surgical Adhesive in General Surgery

NCT ID: NCT01514383

Last Updated: 2019-05-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-10-31

Brief Summary

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The purpose of this study is to evaluate how surgical adhesive is used.

Detailed Description

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In this Case Series Study, clinician experience and subject outcomes will be recorded in the use of a topical skin adhesive (Octylseal) on the closure of skin incisions from General surgical procedures.

Conditions

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Wounds

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Surgical Adhesive

The surgical adhesive (cyanoacrylate) will be used once to close the topical skin surgical incision created during surgical procedures.

Group Type EXPERIMENTAL

Cyanoacrylate (Octylseal )

Intervention Type DEVICE

surgical adhesive

Interventions

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Cyanoacrylate (Octylseal )

surgical adhesive

Intervention Type DEVICE

Other Intervention Names

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cyanoacrylate

Eligibility Criteria

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Inclusion Criteria

* Candidate for use of a topical surgical skin adhesive

Exclusion Criteria

* Subjects with know sensitivity to topical surgical tissue adhesive products or degrading products (cyanoacrylates or formaldehyde)
* Subjects with a history of keloid formation, hypotension, insulin dependent diabetes mellitus, blood/clotting disorders, peripheral vascular diseases or hypertrophy history
* Subjects who present with a contraindications for product usage as per labeling
* A wound with evidence of active infection or gangrene or wounds of decubitus etiology
* Mucosal surfaces or across mucocutaneous junctions or skin that might be exposed to bodily fluids or with dense natural hair
* Subjects with known hypersensitivity to cyanoacrylate or formaldehyde
Minimum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medline Industries

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ed Drower, MS

Role: STUDY_DIRECTOR

Medline Industries

Locations

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Jersey City Medical Center

Jersey City, New Jersey, United States

Site Status

Wyckoff Hospital

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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R11-009

Identifier Type: -

Identifier Source: org_study_id

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