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Octylseal Surgical Adhesive in General Surgery

This study is currently recruiting participants.
Verified January 2012 by Medline Industries
Sponsor:
Information provided by (Responsible Party):
Medline Industries
ClinicalTrials.gov Identifier:
NCT01514383
First received: January 12, 2012
Last updated: January 20, 2012
Last verified: January 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Wounds
 Device: Cyanoacrylate (Octylseal )
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Octylseal as a Topical Surgical Skin Incision Adhesive in General Surgery: A Case Series

Further study details as provided by Medline Industries:

Primary Outcome Measures:
  • Wound closure [ Time Frame: 2-14 days ] [ Designated as safety issue: Yes ]
    Evaluation of wound closure out to 14 days


Estimated Enrollment: 50
Study Start Date: January 2012
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Surgical Adhesive
cyanoacrylate
 Device: Cyanoacrylate (Octylseal )
surgical adhesive
Other Name: cyanoacrylate

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Medline Industries
ClinicalTrials.gov Identifier: NCT01514383     History of Changes
Other Study ID Numbers: R11-009
Study First Received: January 12, 2012
Last Updated: January 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Medline Industries:
wounds

ClinicalTrials.gov processed this record on June 17, 2013