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

Primary Purpose

Blepharoptosis

Status
Terminated
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Bilateral Upper eyelid blepharoplasty
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blepharoptosis focused on measuring Blepharoptosis, Dermatochalasis, octyl 2-cyanoacrylate, Suture Techniques, Tissue Adhesive

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Ophthalmology of Federal University of Sao Paulo

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Experimental operatory wound closure with liquid bandage (Johnson & Johnson, Skillman, NJ, USA).

Outcomes

Primary Outcome Measures

The overall cosmetic outcome of wound closure technique (experimental: tissue adhesive Octyl-2-cyanoacrylate versus control: traditional nylon suture).

Secondary Outcome Measures

Full Information

First Posted
December 31, 2008
Last Updated
December 31, 2008
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT00816270
Brief Title
Liquid Bandage (2-Octyl-Cyanoacrylate) in Upper Lid Blepharoplasty
Official Title
Comparison Between Liquid Bandage(2-Octyl-Cyanoacrylate)and Traditional Suture Closure in Upper Lid Blepharoplasty
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Terminated
Why Stopped
Experimental results were unsatisfatory compared with control.
Study Start Date
April 2008 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blepharoptosis
Keywords
Blepharoptosis, Dermatochalasis, octyl 2-cyanoacrylate, Suture Techniques, Tissue Adhesive

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Experimental operatory wound closure with liquid bandage (Johnson & Johnson, Skillman, NJ, USA).
Intervention Type
Procedure
Intervention Name(s)
Bilateral Upper eyelid blepharoplasty
Other Intervention Name(s)
Liquid bandage (Johnson & Johnson, Skillman, NJ, USA), nylon continuous sutures (Ethicon, Norderstedt, Germany)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angelino J Cariello, MD
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology of Federal University of Sao Paulo
City
Sao Paulo
ZIP/Postal Code
04023-900
Country
Brazil

12. IPD Sharing Statement

Citations:
Citation
Veloudios A, Kratky V. Cyanoacrylate Tissue Adhesive in Blepharoplasty. Ophthalm Plastic Reconstr Surg 1996;12(2):89-97. Greene D, Koch RJ, Goode RL. Efficacy of Octyl-2-Cyanoacrylate Tissue Glue in Blepharoplasty. Arch Facial Plast Surg 1999;1:292-6. Davis SC, Eaglstein WH, Cazzaniga AL, Mertz PM. An octyl-2-cyanoacrylate formulation speeds healing of partial-thickness wounds. Dermatol Surg 2001;27:783-8.
Results Reference
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Liquid Bandage (2-Octyl-Cyanoacrylate) in Upper Lid Blepharoplasty

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