Utility of 2- Octyl Cyanoacrylate (2-OCA)

NCT05278013 | Unknown

• 1 other identifier: 067.IMD.2020.D
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ascites; Fluid Loss

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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.

• Number of participants with complications from paracentesis procedure

  Cellulitis, peritonitis, bleeding, perforated viscus

  up to 1 year

• Number of participants with Evidence of Skin Reactions

  itching, burning, sensation, redness, dermatitis

  up to 1 year

Study Arms (2)

Glue Group (GG)

EXPERIMENTAL

Randomization will take place utilizing serial randomization to Glue Group (GG) and No Glue Group (NG) where skin closure will be assigned serially to a week of GG alternating with a week NG.

Other: Dermabond

No Glue Group (NG)

NO INTERVENTION

Randomization will take place utilizing serial randomization to Glue Group (GG) and No Glue Group (NG) where skin closure will be assigned serially to a week of GG alternating with a week NG.

Interventions

Dermabond OTHER

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.

Glue Group (GG)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

Methodist Dallas Medical Center Pharmacy

Dallas, Texas, 75203, United States

Location

MeSH Terms

Conditions

Ascites

Interventions

octyl 2-cyanoacrylate

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ahmed Alobaidi, MD

  Methodist Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: For the GG, the puncture site edges will be approximated between the index and thumb fingers of the practitioner. After ensuring that the puncture edges are approximated, at least two layers of 2-OCA will be applied topically over the skin to cover the puncture site. At least 30 seconds will be allowed for each layer to dry before application of the second layer. For the NG, the puncture area will be covered using the occlusive dressing supplied in the Safe-T-Centesis kit after catheter withdrawal and cleaning/drying of the skin.

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: March 14, 2022
• Study Start: January 13, 2022
• Primary Completion: January 13, 2024
• Study Completion: January 13, 2024
• Last Updated: July 10, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)