Utility of 2- Octyl Cyanoacrylate (2-OCA)

Methodist Health System

Status: Invitation-only

Conditions: Fluid Loss; Ascites

Treatments: Other: Dermabond

Study type: Interventional

Funder types: Other

Identifiers

NCT05278013

067.IMD.2020.D

Details and patient eligibility

About

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.

Full 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

Enrollment: 134 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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134 participants in 2 patient groups

Glue Group (GG)

Experimental group

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.

Treatment:

Other: Dermabond

No Glue Group (NG)

No Intervention group

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.