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About
Utilizing wound healing trajectory analysis, patient-reported pain and QOL assessment, quantitative bacteriology, and inflammatory infiltrate quantification, an improvement in wound healing will be observed on a cellular, histomorphological and clinical level in the presence of a bioelectric dressing applied in conjunction with SOC.
Full description
The PROCELLERA Antimicrobial Wound Dressing is considered a non-interactive wound dressing containing silver and zinc, classification product code MGP. Non-interactive wound dressings are considered by FDA to be non-significant risk, as per their Investigational Device Exemptions Manual (publication FDA 96-4159).
Procellera is FDA cleared under K081977 for professional use as a wound dressing for partial and full-thickness wounds.
Selection of Subjects
Type of the Subject Population
As a military-civilian cooperative Phase II prospective randomized trial, the study population will include chronic wound patients from both military and civilian backgrounds.
As incidence of complex non-healing wounds remains high in both military and civilian hospital settings, it is estimated that recruitment rate will be sufficiently rapid at each research site. While unanticipated delays (e.g. slow accrual) may occur, the limited patient population and length of time allotted for the clinical study (2 years) is assumed to offset any delays. A total of 60 participants will be enrolled studywide to obtain 50 evaluable participants from both sites combined. Up to 16 patients will be screened each day. A consecutive series of patients who meet the following inclusion/exclusion criteria and agree to participate will be recruited.
Inclusion and Exclusion Criteria
Inclusion Criteria > 18 years of age or older, male or female
Exclusion Criteria
Enrollment
Sex
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Volunteers
Inclusion criteria
> 18 years of age or older, male or female
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
2 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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