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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00855569
Acronym
Stasilon
Enrollment
20
Registered
2009-03-04
Start date
2008-06-30
Completion date
2010-12-31
Last updated
2017-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wounds

Keywords

allografting

Brief 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.

Interventions

DEVICEStasilon

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

Sponsors

University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026