NCT00855569

Hemostatic Textile to Control Bleeding at Donor Graft Sites

Use of a HemostaticTextile (StasilonTM) to Control Bleeding at Skin Graft Donor Sites (Randomized, Single-Blind)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The rationale underlying the study is that donor site bleeding is common and often problematic when presenting to the burn surgeon or staff. Frequently, gauze wound dressings are not sufficiently hemostatic to control a donor site bleed thereby leading to administration of vasoconstrictive agents and repeated application of wound dressing/pressure. The hemostatic textile Stasilon™ has proven superior to gauze in reducing bleeding from anesthetized pigs undergoing standardized surgically-induced trauma. Also, observational case reports have noted cessation of bleeding in a limited number of human patients with difficult to control bleeds.

Conditions

• Wounds

Interventions

Type	Name	Description
DEVICE	Stasilon	Stasilon and gauze will be applied to donor site. Dressings will be collected and evaluated for amount of shed blood.

Timeline

• Start date: 2008-06-01
• Primary completion: 2010-09-01
• Completion: 2010-12-01
• First posted: 2009-03-04
• Last updated: 2017-12-12

Locations

1 site across 1 country: United States