Status:
COMPLETED
Procellera® Compared to Standard of Care Treatment in Mitigating Biofilm Formation in Acute Trauma and Burn Wounds
Lead Sponsor:
The Metis Foundation
Collaborating Sponsors:
Indiana University
Conditions:
Trauma-related Wound
Burn, Partial Thickness
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 dress...
Detailed Description
The healing of traumatic wounds, to include burns, can be compromised by the presence of infection so efforts are made to prevent or diagnose infection early in order to mitigate the negative impact o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 3 2020
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT04079998
Start Date
February 28 2019
End Date
December 3 2020
Last Update
January 22 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234