Wound healing, or wound repair, is the critical physiological process by which the body repairs skin or organ tissue after injury. It can be divided into four major phases: hemostasis, inflammatory, proliferative and remodeling. Hemostasis typically begins immediately after injury, and a fibrin clot forms within minutes to control blood loss. Disturbed wound healing can correlate with increased morbidity and mortality.
Fibrin Clot Formation
Fibrin clot formation is both the final phase of coagulation and the first phase of wound healing. During this process, thrombin (FIIa) converts fibrinogen to fibrin, and activates Factor XIII (FXIII), which forms bonds cross-linking fibrin polymers. The resulting fibrin network is the basis for the hemostatic plug. After fibrin completes its role in wound healing, it is dissolved by physiological fibrinolysis. An increase in fibrinolysis may disturb wound healing.
Fibrin sealants mimic physiological fibrin clot formation. When mixed for use, fibrin sealants consist of a fibrinogen solution and a thrombin solution. The fibrinogen solution may contain FXIII; fibrin sealants typically contain antifibrinolytics. When the two solutions are mixed, a fibrin clot forms within minutes. The added antifibrinolytic (for example, aprotinin) prevents early degradation of the fibrin by proteolytic enzymes.
Fibrin sealing is only a small part of the surgical toolkit, and cannot replace traditional surgical closure techniques like suturing, clipping or stapling. However, fibrin sealants can improve the surgical technique – for instance, by securing sutures against fluid loss, closing air leaks, or stopping oozing in certain organ wounds.
Beriplast P Combi Set
Beriplast P Combi-Set is CSL Behring’s biosurgical fibrin sealant kit. It consists of highly purified biological components (freeze-dried fibrinogen-factor XIII and thrombin) and solvents (aprotinin and calcium chloride solutions).
Before use, the fibrinogen-factor XIII lyophilisate is reconstituted with the aprotinin solution (Combi-Set I); and the thrombin lyophilisate, with the calcium chloride solution (Combi-Set II). The two solutions are then applied, either successively or simultaneously, by needle, spray or catheter. After mixing, they form a stable fibrin clot within minutes and can stop bleeding, seal suture lines and air leaks, or support wound repair.
Indications/Uses for Beriplast P
Beriplast P from CSL Behring can be used locally as a supportive treatment where standard surgical techniques are insufficient, to improve hemostasis (e.g. oozing in organ tissues, vascular graft operations, tooth extractions in patients under oral anticoagulation, or endoscopic treatment of bleeding gastroduodenal ulcers), to promote adhesion/sealing, or as suture support.
Major areas of use are abdominal surgery (e.g. after rupture or resection of liver, spleen or pancreas), cardiovascular surgery (e.g. during bypass surgery), orthopedic surgery (e.g. after bone marrow removal particularly in patients with bleeding tendency), thoracic surgery (e.g. to seal pulmonary fistulae), neurology (e.g. during plastic surgery of durae or dural repair), and urology (e.g. after resection of renal tumors).
Beriplast P can be applied with special application needles or with spray heads. Catheters or probes are necessary for endoscopic use or during minimally invasive surgery. Using the fibrin sealant in conjunction with fleece, felt or net may also improve the success of hemostasis, sealing or wound repair.
Surgical sealants like Beriplast P are absorbable “physiological” materials. They differ from biologically based surgical adhesives and synthetic surgical glues, which are normally non-absorbable.
Beriplast P has an excellent safety profile. The fibrinogen, factor XIII and thrombin used to create Beriplast P are derived from human blood, and heated (pasteurized) in aqueous solution for 10 hours at 60°C. The risk of virus transmission is further reduced through effective donor screening and product manufacturing processes. However, the risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.