Utility of 2- Octyl Cyanoacrylate (2-OCA)

Ascites Clinical Trial

Official title:

Utility of 2- Octyl Cyanoacrylate (2-OCA) Skin Adhesive for Prevention of Fluid Leaks Following Therapeutic Paracentesis

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05278013
• Other study ID #: 067.IMD.2020.D
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 13, 2022
• Est. completion date: January 13, 2024

Study information

• Verified date: July 2023
• Source: Methodist Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 134
• Est. completion date: January 13, 2024
• Est. primary completion date: January 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Paracentesis procedures performed in the interventional radiology department or by physicians outside of the procedure team.

• Patients who undergo a liver transplant surgery or other abdominal surgeries within 48 hours from the paracentesis procedure.

• Patients that undergo paracentesis using a device or kit other than the 18 gauge Safe-T-Centesis kit

Related Conditions & MeSH terms

• Ascites
• Fluid Loss

Intervention

Other:
• Dermabond
High viscosity Dermabond is a sterile, liquid topical skin adhesive containing monomeric (2-OCA) formulation and the colorant D & C Violet # 2. The product has a syrup-like in viscosity and polymerizes within minutes when applied to the skin. 2-OCA is an effective barrier against microbial penetration by Gram-positive (inc. methicillin-resistant Staphylococcus aureus) and Gram-negative motile and nonmotile species as long the as the film is intact (11-13). The high viscosity of Dermabond is intended to reduce the risk of unintended placement of the adhesive during the application process to other body parts, patient's clothing or in between the skin layers in the wound, which can result in delayed wound healing.

Locations

Country	Name	City	State
United States	Methodist Dallas Medical Center Pharmacy	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Access topical 2-OCA application	To assess if topical 2-OCA application for skin closure would prevent post-paracentesis fluid leaks.	up to 1 year
Primary	Access the rate of complications	Assess the rate of complications after topical 2-OCA application post-paracentesis such as skin infections, peritonitis, perforation of viscus, and bleeding.	up to 1 year
Primary	Access post-paracentesis fluid leaks	Incidence of post-paracentesis fluid leaks within 48 hours of paracentesis and topical 2-OCA application	up to 1 year
Primary	Incidence of bleeding from site	local irritation/burning, infections, and/or perforation within 48 hours post-procedure and topical 2-OCA application.	up to 1 year.
Primary	Number of participants with complications from paracentesis procedure	Cellulitis, peritonitis, bleeding, perforated viscus	up to 1 year
Primary	Number of participants with Evidence of Skin Reactions	itching, burning, sensation, redness, dermatitis	up to 1 year