Liquid Bandage (2-Octyl-Cyanoacrylate) in Upper Lid Blepharoplasty

December 31, 2008 updated by: Federal University of São Paulo

Comparison Between Liquid Bandage(2-Octyl-Cyanoacrylate)and Traditional Suture Closure in Upper Lid Blepharoplasty

The aim of this randomized and masked prospective trial is to compare the effectiveness of Liquid Bandage (Octyl-2-Cyanoacrylate) and 6/0 nylon suture as a wound closure device in upper lid blepharoplasty surgery.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Tissue adhesives have been safely used in a variety of surgical procedures for several years. Butyl-2-cyanoacrylate (Histoacryl) and Octyl-2-cyanoacrylate (Dermabond) was also studied for cosmetic blepharoplasty with satisfactory results. Liquid Bandage (Johnson & Johnson, Skillman, NJ, USA) is a more flexible formulation of octyl-2-cyanoacrylate available in many american drugstores for home use. Animal models shown that this product could accelerate the healing of lamellar wounds and studies in humans have demonstrated its safety and effectiveness as an occlusive protective film over cuts, abrasion and wound surgery. Liquid Bandage was also used as a temporary wound barrier in clear corneal cataract surgery with satisfactory applicability. There is no study in the literature using this device in blepharoplasty yet.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 04023-900
        • Department of Ophthalmology of Federal University of Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients older than 25 years with diagnosis of dermatochalasis who presented surgical indication of primary blepharoplasty.

Exclusion Criteria:

  • Prior eyelid surgery
  • Concomitant ocular or systemic disease or current use of medications that could interfere in coagulation or wound healing (eg, diabetes mellitus, oral acetyl salicylic acid or corticosteroids)
  • Pregnant female
  • Known allergy to cyanoacrylate
  • Inability to return for follow-up consultations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Experimental operatory wound closure with liquid bandage (Johnson & Johnson, Skillman, NJ, USA).
Procedure: Bilateral Upper eyelid blepharoplasty
Bilateral upper lid blepharoplasty was performed on each patient by the same experimented surgeon using a standard technique. One side (right or left upper eyelid) was randomly chosen for experimental closure with liquid bandage and the opposite eyelid served as the control being used a 6/0 nylon continuous sutures.
Other Names:
  • Liquid bandage (Johnson & Johnson, Skillman, NJ, USA)
  • nylon continuous sutures (Ethicon, Norderstedt, Germany)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The overall cosmetic outcome of wound closure technique (experimental: tissue adhesive Octyl-2-cyanoacrylate versus control: traditional nylon suture).
Time Frame: thirty days after surgery
thirty days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Investigators

  • Principal Investigator: Angelino J Cariello, MD, Federal University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

December 31, 2008

First Submitted That Met QC Criteria

December 31, 2008

First Posted (Estimate)

January 1, 2009

Study Record Updates

Last Update Posted (Estimate)

January 1, 2009

Last Update Submitted That Met QC Criteria

December 31, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEP 1716/07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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