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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Blepharoptosis

Intervention / Treatment
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* Procedure: Bilateral Upper eyelid blepharoplasty


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Experimental operatory wound closure with liquid bandage (Johnson & Johnson, Skillman, NJ, USA). | Procedure: Bilateral Upper eyelid blepharoplasty<br>* 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.<br>* Other names: nylon continuous sutures (Ethicon, Norderstedt, Germany);|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blepharoptosis, Dermatochalasis, octyl 2-cyanoacrylate, Suture Techniques, Tissue Adhesive