Procellera® Compared to Standard of Care Treatment in Mitigating Biofilm Formation in Acute Trauma and Burn Wounds

Completed · Not applicable

Conditions studied: Trauma-related Wound, Burn, Partial Thickness

In brief

The objective of the study is to evaluate Procellera® , a novel FDA approved antimicrobial wound dressing in a prospective, randomized, controlled clinical study. The hypothesis is that when the dressing is moistened, the low electric field created by moisture-activated elemental silver and zinc electro-couple will prevent formation of biofilm in wounds or to disrupt existing biofilm.

Key facts

Study ID

NCT04079998

Run by

The Metis Foundation

People needed

38

Starts

2019-02-28

Expected to finish

2020-12-03

Last updated by the study team

2021-01-22

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18-65 years of age
• Willing and able to provide informed consent
• Participant has acute partial-thickness or full-thickness wounds caused by trauma or partial-thickness burns that are ≥ 300 cm2 in size in one contiguous area or two separate wound sites ≥ 150 cm2 each

You may not qualify if…

• Pregnancy
• Prisoner
• Active malignancy or immunosuppressive therapy
• Current systemic steroid use
• Known allergy or sensitivity to silver or zinc
• Participant's proposed study wound site has any of the following conditions:
• Location is on the hands, face or feet
• Full-thickness burn wounds
• Exposure of visceral organs
• Exposure of hardware or prosthetic exposure

Where it is running

• Brooke Army Medical Center — Fort Sam Houston, Texas, United States

Full record on ClinicalTrials.gov

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