Octylseal Surgical Adhesive in General Surgery

Phase 4

Completed

• Conditions: Wounds
• Interventions: Device: Cyanoacrylate (Octylseal )

• Registration Number: NCT01514383
• Lead Sponsor: Medline Industries

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 procedures.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-12
• Study First Submitted QC: 2012-01-20
• Study First Posted: 2012-01-23
• Primary Completion: 2012-09
• Study Completion: 2012-10
• Results First Submitted: 2017-08-28
• Status Verified: 2019-05
• Results First Submitted QC: 2019-05-06
• Last Update Submitted: 2019-05-06
• Results First Posted: 2019-05-07
• Last Update Posted: 2019-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surgical Adhesive	Cyanoacrylate (Octylseal )	The surgical adhesive (cyanoacrylate) will be used once to close the topical skin surgical incision created during surgical procedures.

Primary Outcome Measures

Name	Time	Method
Wound Length Closure	During Surgery	Primary incision wound length treatment in adult and pediatric general surgery

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Wyckoff Hospital; 🇺🇸 New York, New York, United States

Jersey City Medical Center; 🇺🇸 Jersey City, New Jersey, United States