Utility of 2- Octyl Cyanoacrylate (2-OCA)

Last updated: July 6, 2023
Sponsor: Methodist Health System
Overall Status: Active - Enrolling

Phase

N/A

Condition

Liver Disease

Treatment

Dermabond

Clinical Study ID

NCT05278013
067.IMD.2020.D
  • Ages 18-100
  • All Genders

Study Summary

Paracentesis is a commonly performed procedure in the inpatient and outpatient settings for treatment of ascites. The most frequent complication of paracentesis is fluid leak. Risk for this complication can be reduced by following the Z-track technique; however, fluid leaks still occur causing significant morbidity. 2-Octyl cyanoacrylate (2-OCA, Dermabond manufactured by Ethicon Inc) skin adhesive has been used for years for skin closure for wounds from surgical incisions including punctures from minimally invasive surgery and simple trauma lacerations.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Inpatients at Methodist Dallas Medical Center (MDMC) ≥18 years of age with ascitesrequiring therapeutic paracentesis performed by the procedure team at the bedside.

Exclusion

Exclusion Criteria:

  • Paracentesis procedures performed in the interventional radiology department or byphysicians outside of the procedure team.
  • Patients who undergo a liver transplant surgery or other abdominal surgeries within 48hours from the paracentesis procedure.
  • Patients that undergo paracentesis using a device or kit other than the 18 gaugeSafe-T-Centesis kit

Study Design

Total Participants: 134
Treatment Group(s): 1
Primary Treatment: Dermabond
Phase:
Study Start date:
January 13, 2022
Estimated Completion Date:
January 13, 2024

Study Description

Paracentesis is a commonly performed procedure in the inpatient and outpatient settings for treatment of ascites. The most frequent complication of paracentesis is fluid leak. Risk for this complication can be reduced by following the Z-track technique; however, fluid leaks still occur causing significant morbidity. 2-Octyl cyanoacrylate (2-OCA, Dermabond manufactured by Ethicon Inc) skin adhesive has been used for years for skin closure for wounds from surgical incisions including punctures from minimally invasive surgery and simple trauma lacerations. It has also been used for treatment of ascites fluid leaks following paracentesis with success in case reports. While the initial FDA approval included a contraindication for use on mucosal surfaces, some evidence in literature suggests that use on mucosal surfaces might warrant further investigation. For example, 2-OCA has been used for repair of a lacerated tongue of a pediatric patient and for closure of congenital cleft lips

Connect with a study center

  • Methodist Dallas Medical Center Pharmacy

    Dallas, Texas 75203
    United States

    Site Not Available

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