NCT00307515

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

A Prospective, Randomized, Controlled Evaluation of Fibrin Sealant 2 (FS2) as an Adjunct to Hemostasis for Soft Tissue Bleeding During Retroperitoneal or Intra-Abdominal Surgery

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Ethicon, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

The time it will take to stop bleeding will be measured and compared between patients who are treated with fibrin sealant 2 to those who are treated with Surgicel®.

Conditions

• Blood Loss, Surgical

Interventions

Type	Name	Description
DRUG	Fibrin Sealant 2 (FS2)	FS2 Surgical Sealant Kit: Biological Active Component containing Human Fibrinogen 55-85 mg/mL and Thrombin containing Thrombin 800-1200 IU/mL and Calcium Chloride 5.6-6.2 mg/mL
DEVICE	Oxidized Regenerated Cellulose (Surgicel)	Commercially available Surgicel used within label.

Timeline

• Start date: 2006-02-01
• Primary completion: 2006-12-01
• Completion: 2006-12-01
• First posted: 2006-03-28
• Last updated: 2009-01-09

Locations

16 sites across 1 country: United States