Recruitment

Recruitment Status
Terminated
Estimated Enrollment
160

Inclusion Criterias

18 years of age or older.
Must be able to understand and sign an informed consent when applicable and Health Insurance Portability and Accountability Act(HIPAA) form that has been approved by an Institutional Review Board (IRB) or follow standard informed consent procedure of the IRB
Any laceration caused by trauma and involving the skin of the upper and/or lower eyelid.
18 years of age or older.
Must be able to understand and sign an informed consent when applicable and Health Insurance Portability and Accountability Act(HIPAA) form that has been approved by an Institutional Review Board (IRB) or follow standard informed consent procedure of the IRB
Any laceration caused by trauma and involving the skin of the upper and/or lower eyelid.

Exclusion Criterias

Eyelid lacerations that include avulsion or missing eyelid tissue
Patients with known hypersensitivity to octyl-2-cyanoacrylate or previous poor reaction to octyl-2-cyanoacrylate
Eyelid lacerations resulting in necrosis or ischemia of tissue prior to repair
...
Eyelid lacerations that include avulsion or missing eyelid tissue
Patients with known hypersensitivity to octyl-2-cyanoacrylate or previous poor reaction to octyl-2-cyanoacrylate
Eyelid lacerations resulting in necrosis or ischemia of tissue prior to repair
Patients who demonstrate intoxication or mental status changes that would make them unfit to provide informed consent for repair

Summary

Conditions
Eyelid Laceration
Type
Interventional
Phase
Phase 4
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

This project is a randomized, controlled trial investigating the cosmetic appearance after repair of traumatic lid lacerations with three different approaches to skin closure: absorbable sutures (surgical gut suture), non-absorbable sutures (polypropylene suture), and tissue adhesive (octyl-2-cyanoa...

This project is a randomized, controlled trial investigating the cosmetic appearance after repair of traumatic lid lacerations with three different approaches to skin closure: absorbable sutures (surgical gut suture), non-absorbable sutures (polypropylene suture), and tissue adhesive (octyl-2-cyanoacrylate). The population will include patients presenting to Memorial Hermann Hospital requiring repair of traumatic lid lacerations. The study will include partial thickness, full-thickness, and margin-involving lacerations where first standard layered tarsal and marginal suture repair will be performed if necessary, and then the patient will be randomized to superficial skin closure with either polypropylene suture closure, surgical gut suture closure, or tissue adhesive closure. Subjects will be followed in an outpatient setting at 1 week and 1 month post-repair at which time standardized photographs will be taken and later assessed using two standardized appearance assessment tools: Visual Analogue Scale (VAS) and Hollander Wound Evaluation Score (HWES).

Inclusion Criterias

18 years of age or older.
Must be able to understand and sign an informed consent when applicable and Health Insurance Portability and Accountability Act(HIPAA) form that has been approved by an Institutional Review Board (IRB) or follow standard informed consent procedure of the IRB
Any laceration caused by trauma and involving the skin of the upper and/or lower eyelid.
18 years of age or older.
Must be able to understand and sign an informed consent when applicable and Health Insurance Portability and Accountability Act(HIPAA) form that has been approved by an Institutional Review Board (IRB) or follow standard informed consent procedure of the IRB
Any laceration caused by trauma and involving the skin of the upper and/or lower eyelid.

Exclusion Criterias

Eyelid lacerations that include avulsion or missing eyelid tissue
Patients with known hypersensitivity to octyl-2-cyanoacrylate or previous poor reaction to octyl-2-cyanoacrylate
Eyelid lacerations resulting in necrosis or ischemia of tissue prior to repair
...
Eyelid lacerations that include avulsion or missing eyelid tissue
Patients with known hypersensitivity to octyl-2-cyanoacrylate or previous poor reaction to octyl-2-cyanoacrylate
Eyelid lacerations resulting in necrosis or ischemia of tissue prior to repair
Patients who demonstrate intoxication or mental status changes that would make them unfit to provide informed consent for repair

Locations

Houston, Texas, 77030
Houston, Texas, 77030

Tracking Information

NCT #
NCT01918059
Collaborators
Not Provided
Investigators
  • Principal Investigator: Judianne Kellaway, MD The University of Texas Health Science Center, Houston
  • Judianne Kellaway, MD The University of Texas Health Science Center, Houston