Utility of 2- Octyl Cyanoacrylate (2-OCA)
- Conditions
- AscitesFluid Loss
- Interventions
- Other: Dermabond
- Registration Number
- NCT05278013
- Lead Sponsor
- Methodist Health System
- 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
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 134
- Inpatients at Methodist Dallas Medical Center (MDMC) ≥18 years of age with ascites requiring therapeutic paracentesis performed by the procedure team at the bedside.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Glue Group (GG) Dermabond 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.
- Primary Outcome Measures
Name Time Method Incidence of bleeding from site up to 1 year. local irritation/burning, infections, and/or perforation within 48 hours post-procedure and topical 2-OCA application.
Number of participants with Evidence of Skin Reactions up to 1 year itching, burning, sensation, redness, dermatitis
Access the rate of complications up to 1 year 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 up to 1 year Incidence of post-paracentesis fluid leaks within 48 hours of paracentesis and topical 2-OCA application
Access topical 2-OCA application up to 1 year To assess if topical 2-OCA application for skin closure would prevent post-paracentesis fluid leaks.
Number of participants with complications from paracentesis procedure up to 1 year Cellulitis, peritonitis, bleeding, perforated viscus
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Methodist Dallas Medical Center Pharmacy
🇺🇸Dallas, Texas, United States