Octylseal Surgical Adhesive in General Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Medline Industries.
Recruitment status was  Recruiting
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 22, 2014