Octylseal Surgical Adhesive in General Surgery

Evaluation of Octylseal as a Topical Surgical Skin Incision Adhesive in General Surgery: A Case Series

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

Study Overview

• Status: Completed
• Conditions: Wounds
• Intervention / Treatment: Device: Cyanoacrylate (Octylseal )

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 procedures.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Jersey City, New Jersey, United States, 07302
      • Jersey City Medical Center
  • New York
    • New York, New York, United States, 11237
      • Wyckoff Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Surgical Adhesive; The surgical adhesive (cyanoacrylate) will be used once to close the topical skin surgical incision created during surgical procedures.	Device: Cyanoacrylate (Octylseal ); surgical adhesive; Other Names: cyanoacrylate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound Length Closure	Primary incision wound length treatment in adult and pediatric general surgery	During Surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With a Score of "0" (No Hurt) on the Pain Rating Scale	Pain was assessed using the Wong-Baker FACES™ Pain Rating Scale, with 0 =No Hurt to 10=Hurts Worst	At Surgery

Collaborators and Investigators

• Sponsor: Medline Industries

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: January 12, 2012
• First Submitted That Met QC Criteria: January 20, 2012
• First Posted (Estimate): January 23, 2012

Study Record Updates

• Last Update Posted (Actual): May 7, 2019
• Last Update Submitted That Met QC Criteria: May 6, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: wounds
• Other Study ID Numbers: R11-009