Hemostatic Textile to Control Bleeding at Donor Graft Sites

Wounds Clinical Trial

— Stasilon  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00855569
• Other study ID #: PREN-101
• Status: Completed
• Phase: N/A
• First received: March 2, 2009
• Last updated: December 8, 2017
• Start date: June 2008
• Est. completion date: December 2010

Study information

• Verified date: June 2012
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Wounds

Intervention

Device:
• Stasilon
Stasilon and gauze will be applied to donor site. Dressings will be collected and evaluated for amount of shed blood.

Locations

Country	Name	City	State
United States	North Carolina Jaycee Burn Center	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the efficacy of a new hemostatic textile named Stasilon™ against standard wound dressings in controlling burn patient donor graft site bleeding.		At the time of surgery