A Retrospective, Observational Study of the Real-world Safety and Performance of InnovaMatrix® AC at a Single Centre

NCT07170566 | Completed FDA Device

• 1 other identifier: WC-23-444
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound Heal

Outcome Measures

Primary Outcomes (1)

• Percent Area Reduction

  Percent area reduction of target wound area at 4 weeks compared to baseline will be listed and tabulated over all eligible subjects, as calculated by wound length multiplied by wound width.

  4 months

Secondary Outcomes (3)

• Time to Complete Wound Closure

  4 months

• Percent Granulation Tissue

  5 months

• Change in percent epithelialisation tissue

  4 months

Study Arms (1)

Subjects with Hard to Heal Wounds Who are Treated with InnovaMatric AC

Adult subjects seen at the study site between 1 May 2022 (the date of first product use according to the study site) to 27 March 2024 (the date of contract signature), who meet the inclusion and exclusion criteria. There will be no new patient visits associated with this retrospective study, therefore patient duration is not applicable.

Device: innovaMatrix AC

Interventions

innovaMatrix AC DEVICE

nnovaMatrix® AC consists of ECM derived from porcine placental material. The device is supplied in a variety of sterile sheet configurations. It is packaged in double peel-open packages and is intended for single use only. The device is terminally sterilised using E-Beam sterilisation and is for licensed healthcare practitioner use only. InnovaMatrix® AC is composed of collagen, elastin, laminin, fibronectin, hyaluronic acid and sulphated glycosaminoglycans. The wound dressing is provided in sheets that are approximately 40-100 microns thick in sizes ranging from 1 x 1cm to 5 x 5cm. They are provided as single-use, sterile wound coverings. InnovaMatrix® AC received Food and Drug Administration (FDA) clearance under K193552 on October 21, 2020. InnovaMatrix® AC has an FDA classification of KGN, which designates it as a collagen wound dressing.

Subjects with Hard to Heal Wounds Who are Treated with InnovaMatric AC

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult subjects seen at the study site between 1 May 2022 (the date of first product use according to the study site) to 27 March 2024 (the date of contract signature), who meet the inclusion and exclusion criteria. There will be no new patient visits associated with this retrospective study, therefore patient duration is not applicable.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ConvaTec Inc.: lead
• Charleston Wound Care Centre: collaborator

Study Sites (1)

Charleston Wound Care Centre

Mt. Pleasant, South Carolina, 29464, United States

Location

Study Officials

• Christopher Dr Michaelis, DO

  Charleston Wound Care Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: September 12, 2025
• Study Start: May 1, 2024
• Primary Completion: June 5, 2025
• Study Completion: August 5, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)