Octylseal Surgical Adhesive in General Surgery

Medline Industries

Status and phase: Completed; Phase 4

Conditions: Wounds

Treatments: Device: Cyanoacrylate (Octylseal )

Study type: Interventional

Funder types: Industry

Identifiers

NCT01514383

R11-009

Details and patient eligibility

About

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

Full 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 procedures.

Enrollment: 34 patients

Sex: All

Ages: 8+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

Surgical Adhesive

Experimental group

Description:

The surgical adhesive (cyanoacrylate) will be used once to close the topical skin surgical incision created during surgical procedures.

Treatment:

Device: Cyanoacrylate (Octylseal )