C.2018.065

About this trial

Last updated 5 years ago

Study ID

C.2018.065

Status

Completed

Type

Interventional

Phase

N/A

Placebo

Accepting

18 to 65 Years

All

Not accepting

Healthy Volunteers

Trial Timing

Ended 5 years ago

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.

Inclusion Criteria

- 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

Exclusion Criteria

- 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

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