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

Blepharoptosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00816270
• Other study ID #: CEP 1716/07
• Status: Terminated
• Phase: N/A
• First received: December 31, 2008
• Last updated: December 31, 2008
• Start date: April 2008
• Est. completion date: July 2008

Study information

• Verified date: December 2008
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of HealthBrazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blepharoptosis

Intervention

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.

Locations

Country	Name	City	State
Brazil	Department of Ophthalmology of Federal University of Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The overall cosmetic outcome of wound closure technique (experimental: tissue adhesive Octyl-2-cyanoacrylate versus control: traditional nylon suture).		thirty days after surgery	Yes