Hemostatic Effect of Vivostat Patient-Derived Fibrin Sealant on Split-Thickness Skin Graft Donor Sites

Abstract

Topical hemostatic agents are used frequently to control bleeding of skin graft donor sites. In this study, the hemostatic properties of Vivostat (Vivolution A/S, Birkerød, Denmark) patient-derived fibrin sealant were compared with a control group of spray thrombin solution, which is considered an industry standard for topical hemostasis. Treatments were applied simultaneously to two randomly chosen halves of a single split-thickness single donor site in patients in five United States surgical centers. The time to achieve satisfactory hemostasis (< or =10 min) was estimated on each half of the wound as the time at which active bleeding had stopped and the wound was suitable for application of a surgical dressing. The time to hemostasis of wounds treated with Vivostat (Vivolution A/S) patient-derived sealant was significantly shorter in comparison with wounds treated with thrombin solution (medians: Vivostat, 31 seconds; thrombin, 58 seconds; p=0.0012). No abnormalities in wound healing were reported for either treatment site 1 week after the operation. Vivostat (Vivolution A/S) sealant is a more rapidly effective topical hemostatic agent than thrombin on split-thickness skin graft donor sites.

A Comparison of the Haemostatic Effect of Vivostat^® Patient-Derived Fibrin Sealant with Oxidised Cellulose (Surgicel^®) in Multiple Surgical Procedures

“…In the present study, there were no adverse events associated with the use of Vivostat sealant; this is consistent with previous clinical studies demonstrating the safe and effective use of the Vivostat system [22, 23, 24]. In a pilot clinical study of the Vivostat system in coronary artery bypass graft surgery, in comparison with conventional haemostatic measures, time to haemostasis was not determined [22].…”

“…The time to haemostasis of Vivostat-derived fibrin sealant, compared with no treatment, was significantly reduced from a maximum-recorded mean time of 180 to 43 s (p < 0.001). More recently, Vivostat sealant has been shown to reduce the time to haemostasis in skin graft donor compared with thrombin solution [24]. …”

Management of bleeding and coagulopathy following major trauma: an updated European guideline

“…• Fibrin and synthetic glues or adhesives have both haemostatic and sealant properties, and their significant effect on haemostasis has been shown in several human randomised controlled studies involving vascular, bone, skin and visceral surgery [300-302]…”

Management of bleeding following major trauma: an updated European guideline

“…iv) Fibrin and synthetic glues or adhesives have both haemostatic and sealant properties and their significant effect on haemostasis have been shown in several human RCTs involving vascular, bone, skin and visceral surgery [176-178]. …”