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Also known as Fibrin Sealant
Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with/mL thrombin and synthetic aprotinin · 5 trials · 6 indications
Hemostasis at the study suture line must be maintained until closure of the surgical wound.
Investigators were shown videos of bleeding severities to standardize assessments. Moderate bleeding defined as: * Either \>25% of the suture line bleeds, or * ≥5 suture line bleedings were present, if counting of suture line bleedings was possible, or * 1 pulsatile suture line bleeding was present.
Investigators were shown videos of bleeding severities to standardize assessments. Severe bleeding defined as: * Either \>50% of the suture line bleeds, or * ≥10 suture line bleedings were present, if counting of suture line bleedings was possible, or * \>1 pulsatile suture line bleeding was present, or * ≥1 spurting suture line bleeding was present.
Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.
Study-relevant CSF leakage is defined as one or more of following: 1. Discrete subcutaneous or subgaleal CSF collection (pseudomeningocele) in surgical area confirmed by positive test for β2-transferrin, or by computed tomography (CT) or magnetic resonance imaging (MRI) 2. Epidural CSF collection in surgical area depicted by CT or MRI 3. Leakage of CSF through surgical wound observed during physical examination, confirmed by a positive test for β2-transferrin 4. Progressive pneumatocephalus (air in subarachnoidal space) depicted by repeat CT in absence of CSF drainage.
Study-relevant CSF leakage is defined as one or more of following: 1. Discrete subcutaneous or subgaleal CSF collection (pseudomeningocele) in surgical area confirmed by positive test for β2-transferrin, or by computed tomography (CT) or magnetic resonance imaging (MRI) 2. Epidural CSF collection in surgical area depicted by CT or MRI 3. Leakage of CSF through surgical wound observed during physical examination, confirmed by a positive test for β2-transferrin 4. Progressive pneumatocephalus (air in subarachnoidal space) depicted by repeat CT in absence of CSF drainage.
| Arm | Type | Description |
|---|---|---|
| FS VH S/D 500 s-apr | EXPERIMENTAL | FS VH S/D 500 s-apr will be applied to the study suture line. |
| Manual compression with surgical gauze pads | ACTIVE_COMPARATOR | Dry gauze pads will be positioned to cover the complete study suture line. |
| FS 4IU VH S/D | EXPERIMENTAL | FS 4IU VH S/D was administered intraoperatively to the wound bed by spray application using the TISSOMAT and Spray Set. Only the DUPLOJECTvii system and Spray Set (connection tube with sterile filter and spray head) device was used for simultaneous spray application of the study product. A thin layer of FS 4IU VH S/D was applied to the wound bed using a "painting motion" from side to side to achieve coverage. The recommended dosing volume was 2.0 to 4.0 mL/100 cm2. One 2-mL pack (4 mL total volume) of FS 4IU VH S/D applied using the TISSOMAT and Spray Set was sufficient to coat a wound bed of 100-200 cm2. |
| Staples | ACTIVE_COMPARATOR | Staples are the current standard of care in burn surgery and are well accepted as the control in this type of study. |
| 1 | EXPERIMENTAL | One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care. |
| Standard of Care (Control group) | ACTIVE_COMPARATOR | The treatment of the control group consisted of Standard of Care (SoC) which was defined as the closure of a dura defect by suturing in a patch of autologous fascia, pericranium or suturable collagen based dura substitute. |
| Name | Type | Description |
|---|---|---|
| Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) | BIOLOGICAL | The actual dose of FS VH S/D 500 s-apr will depend on the length of the suture line and the intensity of bleeding (but shall not exceed 4 mL FS VH S/D 500 s-apr). |
| Surgical gauze pads | OTHER | Manual compression with surgical gauze pads |
| Fibrin Sealant, ARTISS 4IU/ml VH SD | BIOLOGICAL | FS 4IU VH S/D, a two-component fibrin sealant with 4 IU/mL human thrombin, vapor heated, solvent detergent treated, provided in a frozen, ready-to-use formulation. Administration by a topical spray application using the TISSOMAT device and Spray Set. |
| Staples | OTHER | Administration by mechanical/multiple point fixation. |
| Fibrin Sealant | DRUG | - |
| Fibrin Sealant with 4 IU/ml Thrombin, Vapor-Heated, Solvent Detergent Treated Containing Synthetic Aprotinin (FS VH S/D 4) | BIOLOGICAL | Each subject received fibrin sealant with 4 IU/mL thrombin, vapor heated, solvent detergent treated containing synthetic aprotinin (FS VH S/D 4 ) to one side of the face. The dosing volume to be applied is 0.02 mL/cm2 to 0.04 mL/cm2. The study product will be applied to the subcutaneous plane in both the neck and the face area. The product will be applied using the spray device provided by the sponsor. (The other side of the face will be treated using standard of care.) |
| Standard of care | PROCEDURE | Standard care: defined as the closure of a dura defect by suturing in a patch of autologous fascia, pericranium or suturable collagen-based dura substitute. |
Inclusion Criteria: Preoperative inclusion criteria: * Subjects undergoing vascular surgery (ie, conduit placement with an ePTFE graft), including arterio-arterial bypasses, including: * axillo-femoral * axillo-bifemoral * aorto-bifemoral * ilio-femoral * femoro-femoral * ilio-poplite...
Fibrin Sealant is used for esophageal and/or gastric varices and deep partial or full thickness wounds. In clinical trials, it has been studied for adhering split thickness skin grafts and improving wound healing in burn patients, as well as for endoscopic injection to treat bleeding esophageal varices.
Fibrin Sealant is developed by Baxter International Inc., a company traded on the New York Stock Exchange under the ticker BAX.
Fibrin Sealant is in Phase 3 clinical development. It is an investigational product and has not been approved by the FDA based on the available information. Two Phase 3 trials have been completed.
Fibrin Sealant has been studied in two completed Phase 3 trials. NCT00157131 evaluated its safety and efficacy in adhering split thickness skin grafts in burn patients with deep partial or full thickness wounds. NCT00161915 compared endoscopic injection of fibrin sealant versus endoscopic ligature for bleeding esophageal varices.
Fibrin Sealant is a small molecule therapeutic. It works by mimicking the final step of the blood coagulation cascade, forming a fibrin clot that adheres to tissues and promotes hemostasis and wound healing. This mechanism is relevant for its use in variceal bleeding and wound closure.