Utility of 2- Octyl Cyanoacrylate (2-OCA)

• Sponsor: Methodist Health System (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05278013
• Collaborator: (none)
• Enrollment: 134
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 11.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ascites; Fluid Loss	Other: Dermabond	N/A

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 134 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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.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)
• Primary Purpose: Health Services Research
• Official Title: Utility of 2- Octyl Cyanoacrylate (2-OCA) Skin Adhesive for Prevention of Fluid Leaks Following Therapeutic Paracentesis
• Actual Study Start Date: Jan 13, 2022
• Anticipated Primary Completion Date: Jan 13, 2023
• Anticipated Study Completion Date: Jan 13, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Glue Group (GG) 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; 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.
No Intervention: No Glue Group (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.

Outcome Measures

Primary Outcome Measures

1. Prevention [up to 1 year]

   to assess if topical 2-OCA application for skin closure would prevent post-paracentesis fluid leaks.

2. Underlying diagnosis for Ascites [up to 1 year]

   Cirrhosis diagnosis ie Alcoholic, NASH, Hepatitis C, Hepatitis B, Autoimmune, PBC, PSC, Wildson

3. Underlying diagnosis for Ascites [up to 1 year]

   Renal Disease

4. Underlying diagnosis for Ascites [up to 1 year.]

   Heart Failure

5. Complications from paracentesis procedure [up to 1 year]

   Cellulitis, peritonitis, bleeding, perforated viscus

6. Evidence of Skin Reactions [up to 1 year]

   itching, burning, sensation, redness, dermatitis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Methodist Dallas Medical Center Pharmacy	Dallas	Texas	United States	75203

Sponsors and Collaborators

• Methodist Health System

Investigators

• Principal Investigator: Ahmed Alobaidi, MD, Methodist Health System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Methodist Health System
• ClinicalTrials.gov Identifier: NCT05278013
• Other Study ID Numbers: 067.IMD.2020.D
• First Posted: Mar 14, 2022
• Last Update Posted: Mar 14, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Ascites

Study Results

No Results Posted as of Mar 14, 2022