Status:
COMPLETED
Octylseal Surgical Adhesive in General Surgery
Lead Sponsor:
Medline Industries
Conditions:
Wounds
Eligibility:
All Genders
8+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate how surgical adhesive is used.
Detailed Description
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 procedure...
Eligibility Criteria
Inclusion
- Candidate for use of a topical surgical skin adhesive
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01514383
Start Date
January 1 2012
End Date
October 1 2012
Last Update
May 7 2019
Active Locations (2)
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1
Jersey City Medical Center
Jersey City, New Jersey, United States, 07302
2
Wyckoff Hospital
New York, New York, United States, 11237