Hemostatic Textile to Control Bleeding at Donor Graft Sites (Stasilon)
This study has been completed.
Sponsor:
University of North Carolina, Chapel Hill
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
| Tracking Information | |||||
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| First Received Date ICMJE | March 2, 2009 | ||||
| Last Updated Date | June 15, 2012 | ||||
| Start Date ICMJE | June 2008 | ||||
| Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00855569 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Hemostatic Textile to Control Bleeding at Donor Graft Sites | ||||
| Official Title ICMJE | Use of a HemostaticTextile (StasilonTM) to Control Bleeding at Skin Graft Donor Sites (Randomized, Single-Blind) | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Patients admitted to the UNC Jaycee Burn Center |
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| Condition ICMJE | Wounds | ||||
| Intervention ICMJE | Device: Stasilon
Stasilon and gauze will be applied to donor site. Dressings will be collected and evaluated for amount of shed blood. |
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| Study Group/Cohort (s) | 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 |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 20 | ||||
| Completion Date | December 2010 | ||||
| Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00855569 | ||||
| Other Study ID Numbers ICMJE | PREN-101 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Preston Rich, MD, University of North Carolina, Chapel Hill | ||||
| Study Sponsor ICMJE | University of North Carolina, Chapel Hill | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of North Carolina, Chapel Hill | ||||
| Verification Date | June 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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