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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00855569
First Posted: March 4, 2009
Last Update Posted: June 18, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Preston Rich, MD, University of North Carolina, Chapel Hill
  Purpose
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.

Condition Intervention Phase
Wounds Device: Stasilon Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Use of a HemostaticTextile (StasilonTM) to Control Bleeding at Skin Graft Donor Sites (Randomized, Single-Blind)

Resource links provided by NLM:


Further study details as provided by Preston Rich, MD, University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: June 2008
Study Completion Date: December 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Each donor site will act as it own control - both dressings will be applied to the donor site and assessments will be made
Device: Stasilon
Stasilon and gauze will be applied to donor site. Dressings will be collected and evaluated for amount of shed blood.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients admitted to the UNC Jaycee Burn Center
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00855569


Locations
United States, North Carolina
North Carolina Jaycee Burn Center
Chapel Hill, North Carolina, United States, 27514
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Preston Rich, MD University of North Carolina, Chapel Hill
  More Information

Responsible Party: Preston Rich, MD, Chief, Trauma, Critical Care, and Emergency Surgery; Associate Professor of Surgery, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00855569     History of Changes
Other Study ID Numbers: PREN-101
First Submitted: March 2, 2009
First Posted: March 4, 2009
Last Update Posted: June 18, 2012
Last Verified: June 2012

Keywords provided by Preston Rich, MD, University of North Carolina, Chapel Hill:
allografting