A Retrospective, Observational Study of the Real-world Safety and Performance of InnovaMatrix® AC… (NCT07170566) | Clinical Trial Compass
CompletedNot Applicable
A Retrospective, Observational Study of the Real-world Safety and Performance of InnovaMatrix® AC at a Single Centre
United States67 participantsStarted 2024-05-01
Plain-language summary
The use of a decellularised porcine placental extracellular matrix in hard-to-heal wounds: A retrospective study of the real-world performance of InnovaMatrix® AC at a single centre.
Who can participate
Age range18 Years – 100 Years
SexALL
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Inclusion Criteria:
* Male and female subjects aged 18 years or older at the time the data were reported.
* Subjects with hard-to-heal wound(s), defined as those that have failed to show improvement (which is defined as ≥50% reduction in wound area) over 4-weeks of standard wound care.
* Initial Wound area that is \>0.5 cm2 and \<10 cm2
* InnovaMatrix® AC applied to target wound(s) for a minimum of two consecutive weekly visits inside a 4-week period.
* Subjects were compliant with wound protection strategies through treatment period (offloading, compression, etc).
* The target wound(s) is not undergoing active management at the time of data entry.
Exclusion Criteria:
* Wound area showed ≥50% reduction in 4-weeks preceding initial InnovaMatrix® AC application.
* Cases where InnovaMatrix® AC was not applied at a minimum of two consecutive weekly visits inside a 4-week period.
* Subjects who were non-compliant with additional wound protection strategies (offloading, compression, etc)
* Subjects with severe comorbidities that significantly impact healing ability, or ability for subject to be compliant with wound protection strategies, such as: peripheral vascular disease (ABI \<0.4, \>1.3)1, severely uncontrolled diabetes (Hgb A1C \>9.0%), neurodegenerative disorders, Charcot foot, high dose corticosteroid or other immunosuppressant, etc
* Wound area \<0.5 cm2 or \>10 cm2
* The target wound is still under active treatment.