Hemostatic Textile to Control Bleeding at Donor Graft Sites (Stasilon)

University of North Carolina (UNC)

Status: Completed

Conditions: Wounds

Treatments: Device: Stasilon

Study type: Observational

Funder types: Other

Identifiers

NCT00855569

PREN-101

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• >/= 18 years old
• burn injury requiring allografting from donor site

Exclusion criteria

• < 18 years
• unable to give consent due to mental or emotional instability

Trial design

20 participants in 1 patient group

1

Description:

Each donor site will act as it own control - both dressings will be applied to the donor site and assessments will be made

Treatment:

Device: Stasilon