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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Preston Rich, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00855569
First received: March 2, 2009
Last updated: June 15, 2012
Last verified: June 2012

March 2, 2009
June 15, 2012
June 2008
September 2010   (final data collection date for primary outcome measure)
To compare the efficacy of a new hemostatic textile named Stasilon™ against standard wound dressings in controlling burn patient donor graft site bleeding. [ Time Frame: At the time of surgery ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00855569 on ClinicalTrials.gov Archive Site
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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)

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.

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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Probability Sample

Patients admitted to the UNC Jaycee Burn Center

Wounds
Device: Stasilon
Stasilon and gauze will be applied to donor site. Dressings will be collected and evaluated for amount of shed blood.
1
Each donor site will act as it own control - both dressings will be applied to the donor site and assessments will be made
Intervention: Device: Stasilon
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
December 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00855569
PREN-101
No
Preston Rich, MD, University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
Not Provided
Principal Investigator: Preston Rich, MD University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP