Target bleeding site is identified on soft tissue during urologic, gynecologic or general surgery procedures: 1) Simple or radical nephrectomies, 2) Total adrenalectomies, 3) Radical prostatectomies, 4) Pyeloplasties, 5) Radical cystectomies, 6) Simple or radical hysterectomies, 7) Lymphadenectomies (in the retroperitoneal or pelvic region only), 8) Retroperitoneal tumor resections, 9) Mastopexies, and 10) Abdominoplasties.
A target bleeding site can be identified.
Target bleeding site has moderate bleeding according to the Investigator's judgment.
You may not be if
Require thoracic, abdominal, retroperitoneal or pelvic surgery due to trauma.
Infection in the anatomic surgical area.
History of severe (e.g. anaphylactic) reactions to blood or to any blood-derived product.
Previous known sensitivity to any FS Grifols component or any Surgicel® component.
Females who are pregnant or nursing a child at Baseline (within 24 hours prior to surgical procedure).
Receiving an organ transplant during the same surgical procedure.
Undergone a therapeutic surgical procedure within 30 days from the screening visit.
A target bleeding site cannot be identified.
The target bleeding site has a mild or severe bleeding.
Occurrence of major intraoperative complications that require resuscitation or deviation from the planned surgical procedure.
Application of any topical haemostatic material on the cut soft tissue surface identified as the target bleeding site prior to application of the study treatment.
Clareo Health | Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Soft Tissue Open Surgeries
