Evaluation of Fibrin Sealant 2 in Retroperitoneal or Intra-Abdominal Surgery

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A comparison of fibrin sealant 2 versus Surgicel® as an addition to standard surgical practice in stopping mild to moderate soft tissue bleeding during retroperitoneal or intra-abdominal surgery.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ethicon, Inc.
• Collaborator: OMRIX Biopharmaceuticals
• Treatments: Fibrin Tissue Adhesive

Criteria

Inclusion Criteria:

• Male and Female subjects requiring non-emergent retroperitoneal or intra-abdominal surgical procedures

• Presence of an appropriate soft-tissue target bleeding site (challenging bleeding site for which topical hemostatic adjuncts might typically be used) as identified intra-operatively by the surgeon

• Subjects must be willing to participate in the study and provide written informed consent

Exclusion Criteria:

• Subjects undergoing emergency surgery

• Parenchymal or anastomotic bleeding sites will not be considered for randomization

• Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure

• Subjects with known intolerance to blood products or to one for the components of the study product

• Subjects unwilling to receive blood products

• Subjects with known autoimmune immunodeficiency diseases (including known HIV

• Subjects who are known, current alcohol and/or drug abusers

• Subjects who have participated in another investigational drug or device research study within 30 days of enrollment

• Female subjects who are pregnant or nursing