Status:
COMPLETED
A Retrospective, Observational Study of the Real-world Safety and Performance of InnovaMatrix® AC at a Single Centre
Lead Sponsor:
ConvaTec Inc.
Collaborating Sponsors:
Charleston Wound Care Centre
Conditions:
Wound Heal
Eligibility:
All Genders
18-100 years
Brief 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.
Detailed Description
Hard-to-heal wounds are defined as wounds that do not transition through the normal phases of healing in a timely manner.1 With a global prevalence of \~1.9 per 1000, it is predicted that the incidenc...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 5 2025
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT07170566
Start Date
May 1 2024
End Date
August 5 2025
Last Update
September 15 2025
Active Locations (1)
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1
Charleston Wound Care Centre
Mt. Pleasant, South Carolina, United States, 29464