Clinical trial NCT05278013: 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
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Ascites
Fluid Loss
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2022-03-14
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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

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

Primary outcomes:
measure: Access topical 2-OCA application
timeFrame: up to 1 year
measure: Access the rate of complications
timeFrame: up to 1 year
measure: Access post-paracentesis fluid leaks
timeFrame: up to 1 year
measure: Incidence of bleeding from site
timeFrame: up to 1 year.
measure: Number of participants with complications from paracentesis procedure
timeFrame: up to 1 year
measure: Number of participants with Evidence of Skin Reactions
timeFrame: up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center Pharmacy
state: Texas
Study officials:
affiliation: Methodist Health System
name: Ahmed Alobaidi, MD
role: PRINCIPAL_INVESTIGATOR
References: