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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
134
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.
Methodist Dallas Medical Center Pharmacy
Dallas, Texas, United States
Access topical 2-OCA application
To assess if topical 2-OCA application for skin closure would prevent post-paracentesis fluid leaks.
Time frame: up to 1 year
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.
Time frame: up to 1 year
Access post-paracentesis fluid leaks
Incidence of post-paracentesis fluid leaks within 48 hours of paracentesis and topical 2-OCA application
Time frame: up to 1 year
Incidence of bleeding from site
local irritation/burning, infections, and/or perforation within 48 hours post-procedure and topical 2-OCA application.
Time frame: up to 1 year.
Number of participants with complications from paracentesis procedure
Cellulitis, peritonitis, bleeding, perforated viscus
Time frame: up to 1 year
Number of participants with Evidence of Skin Reactions
itching, burning, sensation, redness, dermatitis
Time frame: up to 1 year
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