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rdf:type |
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lifeskim:mentions |
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pubmed:issue |
1
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pubmed:dateCreated |
2003-1-24
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pubmed:abstractText |
The safety and effectiveness of Integra Dermal Regeneration Template was evaluated in a postapproval study involving 216 burn injury patients who were treated at 13 burn care facilities in the United States. The mean total body surface area burned was 36.5% (range, 1-95%). Integra was applied to fresh, clean, surgically excised burn wounds. Within 2 to 3 weeks, the dermal layer regenerated, and a thin epidermal autograft was placed. The incidence of invasive infection at Integra-treated sites was 3.1% (95% confidence interval, 2.0-4.5%) and that of superficial infection 13.2% (95% confidence interval, 11.0-15.7%). Mean take rate of Integra was 76.2%; the median take rate was 95%. The mean take rate of epidermal autograft was 87.7%; the median take rate was 98%. This postapproval study further supports the conclusion that Integra is a safe and effective treatment modality in the hands of properly trained clinicians under conditions of routine clinical use at burn centers.
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pubmed:language |
eng
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pubmed:journal |
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pubmed:citationSubset |
IM
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pubmed:chemical |
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pubmed:status |
MEDLINE
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pubmed:issn |
0273-8481
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pubmed:author |
pubmed-author:DeClementFrederick AFA,
pubmed-author:DimickAlan RAR,
pubmed-author:HeimbachDavid MDM,
pubmed-author:HickersonWilliam LWL,
pubmed-author:JordanMarion HMH,
pubmed-author:LutermanArnoldA,
pubmed-author:OzobiaNathanN,
pubmed-author:RyanColleen MCM,
pubmed-author:SaffleJeffrey RJR,
pubmed-author:SheridanRobert LRL,
pubmed-author:VoigtDavid WDW,
pubmed-author:WardenGlenn DGD
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pubmed:issnType |
Print
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pubmed:volume |
24
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pubmed:owner |
NLM
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pubmed:authorsComplete |
Y
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pubmed:pagination |
42-8
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pubmed:dateRevised |
2006-8-15
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pubmed:meshHeading |
pubmed-meshheading:12543990-Adolescent,
pubmed-meshheading:12543990-Adult,
pubmed-meshheading:12543990-Aged,
pubmed-meshheading:12543990-Aged, 80 and over,
pubmed-meshheading:12543990-Biocompatible Materials,
pubmed-meshheading:12543990-Burns,
pubmed-meshheading:12543990-Child,
pubmed-meshheading:12543990-Child, Preschool,
pubmed-meshheading:12543990-Chondroitin Sulfates,
pubmed-meshheading:12543990-Collagen,
pubmed-meshheading:12543990-Dermis,
pubmed-meshheading:12543990-Female,
pubmed-meshheading:12543990-Humans,
pubmed-meshheading:12543990-Infant,
pubmed-meshheading:12543990-Male,
pubmed-meshheading:12543990-Middle Aged,
pubmed-meshheading:12543990-Regeneration,
pubmed-meshheading:12543990-Trauma Severity Indices,
pubmed-meshheading:12543990-United States,
pubmed-meshheading:12543990-Wound Infection
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pubmed:articleTitle |
Multicenter postapproval clinical trial of Integra dermal regeneration template for burn treatment.
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pubmed:affiliation |
Department of Surgery, University of Washington, Seattle, Washington, USA.
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pubmed:publicationType |
Journal Article,
Clinical Trial,
Multicenter Study,
Clinical Trial, Phase IV
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