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

Not Applicable

Terminated

• Conditions: Blepharoptosis

• Registration Number: NCT00816270
• Lead Sponsor: Federal University of São Paulo

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.

Study Timeline

• Study Start: 2008-04
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2008-12
• Study First Submitted: 2008-12-31
• Study First Submitted QC: 2008-12-31
• Last Update Submitted: 2008-12-31
• Study First Posted: 2009-01-01
• Last Update Posted: 2009-01-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Trial Locations

Locations (1)

Department of Ophthalmology of Federal University of Sao Paulo; 🇧🇷 Sao Paulo, Brazil