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Completed

NCT Number: NCT01514383

Octylseal Surgical Adhesive in General Surgery

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

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Key information

Conditions

Wounds Wounds and Injuries

Age range

8 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Jersey City Medical Center, Jersey City, New Jersey, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cyanoacrylate (Octylseal )

Device

surgical adhesive

Other names: cyanoacrylate

Primary outcomes

  1. Wound Length Closure

    Time frame: During Surgery

    Primary incision wound length treatment in adult and pediatric general surgery

Secondary outcomes

  1. Number of Participants With a Score of "0" (No Hurt) on the Pain Rating Scale

    Time frame: At Surgery

    Pain was assessed using the Wong-Baker FACES™ Pain Rating Scale, with 0 =No Hurt to 10=Hurts Worst

Sponsors and collaborators

Lead sponsor

Medline Industries

Industry

Registry information

Official study title

Evaluation of Octylseal as a Topical Surgical Skin Incision Adhesive in General Surgery: A Case Series

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 23, 2012
Registry last updated
May 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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