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Octylseal Surgical Adhesive in General Surgery

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ClinicalTrials.gov Identifier: NCT01514383
Recruitment Status : Unknown
Verified January 2012 by Medline Industries.
Recruitment status was:  Recruiting
First Posted : January 23, 2012
Last Update Posted : January 23, 2012
Sponsor:
Information provided by (Responsible Party):
Medline Industries

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

Condition or disease Intervention/treatment Phase
Wounds Device: Cyanoacrylate (Octylseal ) Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Octylseal as a Topical Surgical Skin Incision Adhesive in General Surgery: A Case Series
Study Start Date : January 2012
Estimated Primary Completion Date : April 2012
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Surgical Adhesive
cyanoacrylate
Device: Cyanoacrylate (Octylseal )
surgical adhesive
Other Name: cyanoacrylate



Primary Outcome Measures :
  1. Wound closure [ Time Frame: 2-14 days ]
    Evaluation of wound closure out to 14 days



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Greater than 18 years of age
  • Candidate for use of a topical surigcal 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 useage 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 blody fluids or with dense natural hair
  • Subjects with known hypersensitivity to cyanoacrylate or formaldehyde

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01514383


Locations
United States, New York
Wyckoff Hospital Recruiting
New York, New York, United States
Contact: Akella Chendresekhar, MD    718-963-7602      
Principal Investigator: Akela Chendresekhar, MD         
Sponsors and Collaborators
Medline Industries

Responsible Party: Medline Industries
ClinicalTrials.gov Identifier: NCT01514383     History of Changes
Other Study ID Numbers: R11-009
First Posted: January 23, 2012    Key Record Dates
Last Update Posted: January 23, 2012
Last Verified: January 2012

Keywords provided by Medline Industries:
wounds