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Utility of 2- Octyl Cyanoacrylate (2-OCA)

Primary Purpose

Ascites, Fluid Loss

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dermabond
Sponsored by
Methodist Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Ascites

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Methodist Dallas Medical Center Pharmacy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Glue Group (GG)

No Glue Group (NG)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Access topical 2-OCA application
To assess if topical 2-OCA application for skin closure would prevent post-paracentesis fluid leaks.
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.
Access post-paracentesis fluid leaks
Incidence of post-paracentesis fluid leaks within 48 hours of paracentesis and topical 2-OCA application
Incidence of bleeding from site
local irritation/burning, infections, and/or perforation within 48 hours post-procedure and topical 2-OCA application.
Number of participants with complications from paracentesis procedure
Cellulitis, peritonitis, bleeding, perforated viscus
Number of participants with Evidence of Skin Reactions
itching, burning, sensation, redness, dermatitis

Secondary Outcome Measures

Full Information

First Posted
February 3, 2022
Last Updated
July 6, 2023
Sponsor
Methodist Health System
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1. Study Identification

Unique Protocol Identification Number
NCT05278013
Brief Title
Utility of 2- Octyl Cyanoacrylate (2-OCA)
Official Title
Utility of 2- Octyl Cyanoacrylate (2-OCA) Skin Adhesive for Prevention of Fluid Leaks Following Therapeutic Paracentesis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 13, 2022 (Actual)
Primary Completion Date
January 13, 2024 (Anticipated)
Study Completion Date
January 13, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Methodist Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ascites, Fluid Loss

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
134 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Glue Group (GG)
Arm Type
Experimental
Arm Description
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.
Arm Title
No Glue Group (NG)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Dermabond
Intervention Description
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.
Primary Outcome Measure Information:
Title
Access topical 2-OCA application
Description
To assess if topical 2-OCA application for skin closure would prevent post-paracentesis fluid leaks.
Time Frame
up to 1 year
Title
Access the rate of complications
Description
Assess the rate of complications after topical 2-OCA application post-paracentesis such as skin infections, peritonitis, perforation of viscus, and bleeding.
Time Frame
up to 1 year
Title
Access post-paracentesis fluid leaks
Description
Incidence of post-paracentesis fluid leaks within 48 hours of paracentesis and topical 2-OCA application
Time Frame
up to 1 year
Title
Incidence of bleeding from site
Description
local irritation/burning, infections, and/or perforation within 48 hours post-procedure and topical 2-OCA application.
Time Frame
up to 1 year.
Title
Number of participants with complications from paracentesis procedure
Description
Cellulitis, peritonitis, bleeding, perforated viscus
Time Frame
up to 1 year
Title
Number of participants with Evidence of Skin Reactions
Description
itching, burning, sensation, redness, dermatitis
Time Frame
up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Alobaidi, MD
Organizational Affiliation
Methodist Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Methodist Dallas Medical Center Pharmacy
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Utility of 2- Octyl Cyanoacrylate (2-OCA)

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