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

NCT00816270 | Terminated DMC

• 1 other identifier: CEP 1716/07
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Blepharoptosis

Keywords

Blepharoptosis; Dermatochalasis; octyl 2-cyanoacrylate; Suture Techniques; Tissue Adhesive

Outcome Measures

Primary Outcomes (1)

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

  thirty days after surgery

Study Arms (1)

1

EXPERIMENTAL

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

Procedure: Bilateral Upper eyelid blepharoplasty

Interventions

Bilateral Upper eyelid blepharoplasty PROCEDURE

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.

Also known as: Liquid bandage (Johnson & Johnson, Skillman, NJ, USA), nylon continuous sutures (Ethicon, Norderstedt, Germany)

1

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Department of Ophthalmology of Federal University of Sao Paulo

São Paulo, São Paulo, 04023-900, Brazil

Location

Related 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.

  BACKGROUND

MeSH Terms

Conditions

Blepharoptosis; Cutis Laxa

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Angelino J Cariello, MD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 31, 2008
• First Posted: January 1, 2009
• Study Start: April 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: January 1, 2009

Record last verified: 2008-12

Locations

BR (1)