NCT05278013

Utility of 2- Octyl Cyanoacrylate (2-OCA)

Utility of 2- Octyl Cyanoacrylate (2-OCA) Skin Adhesive for Prevention of Fluid Leaks Following Therapeutic Paracentesis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sponsor: Methodist Health System · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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

Conditions

• Ascites
• Fluid Loss

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-01-13
• Primary completion: 2024-01-13
• Completion: 2024-01-13
• First posted: 2022-03-14
• Last updated: 2023-07-10

Locations

1 site across 1 country: United States