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This study is evaluating an investigational device (also known as the “study device”) called GATT-Patch as a possible management of minimal to moderate bleeding during liver surgery. An investigational device is one that has not been approved by the United States (US) Food and Drug Administration (FDA).
GATT-Patch is a small, flexible piece of gelatin that contains a man-made substance. When the patch comes into contact with tissue and blood, it adheres to the tissue and encourages the blood to clot and stop or reduce blood loss. Previous animal and human studies suggest that GATT-Patch does this more quickly and effectively than current patches used in liver or gallbladder surgery. Based on previous testing, GATT-Patch is also believed to dissolve within 4-6 weeks, faster than patches currently used in surgery.
Participants will be randomized to receive either the GATT-Patch or Surgicel Original. Randomization is like flipping a coin and there is a 50/50 chance of being assigned to either group.
Participation will entail two follow-up visits post-surgery.
Inclusion Criteria:
Exclusion Criteria:
Detailed eligibility will be discussed when reaching out to the study team.