Multicenter postapproval clinical trial of Integra dermal regeneration template for burn treatment.
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.
Heimbach
David M
DM
Department of Surgery, University of Washington, Seattle, Washington, USA.
Warden
Glenn D
GD
Luterman
Arnold
A
Jordan
Marion H
MH
Ozobia
Nathan
N
Ryan
Colleen M
CM
Voigt
David W
DW
Hickerson
William L
WL
Saffle
Jeffrey R
JR
DeClement
Frederick A
FA
Sheridan
Robert L
RL
Dimick
Alan R
AR
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001672:Biocompatible Materials / Q000009:adverse effects* / Q000627:therapeutic use*; D002056:Burns / Q000150:complications* / Q000401:mortality / Q000628:therapy*; D002648:Child; D002675:Child, Preschool; D002809:Chondroitin Sulfates; D003094:Collagen; D020405:Dermis / Q000503:physiopathology*; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D012038:Regeneration / Q000502:physiology*; D015599:Trauma Severity Indices; D014481:United States; D014946:Wound Infection / Q000209:etiology* / Q000401:mortality / Q000503:physiopathology*
D001672:Biocompatible Materials; C114835:integra artificial skin; D002809:Chondroitin Sulfates; D003094:Collagen