Clinical and Mechanistic Demonstration of a Bioelectric Dressing System for Non-healing Wound Management: A Phase II Trial
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|ClinicalTrials.gov Identifier: NCT01784887|
Recruitment Status : Terminated (Did not have study population to continue)
First Posted : February 6, 2013
Last Update Posted : May 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Non-healing Soft Tissue Wounds||Drug: Procellera||Phase 1 Phase 2|
Hide Detailed 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
- At least 18 years old
- Male or female
- All ethnic groups
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
- 18 years of age or older, male or female
- Female subject not pregnant - pregnancy excluded by HCG (urine or serum) or by history (tubal ligation, hysterectomy, or menopause).
- Have a non-healing external wound at any location of the body of ≥90 days duration that is (10-50 cm2) at initial screening and does not exceed 3 cm in depth.
- May have a wound requiring Negative Pressure Wound Therapy in conjunction with standard of care wound treatment.
- Subject is able to apply study dressing to his/her wound, or have a reliable and capable caregiver to do it.
- Subjects will have adequate blood flow to the wound as defined by Skin Perfusion Pressure (SPP)47-49 of >30mmHg recorded over intact epidermis near the open wound margin.
- Subjects with arterial repairs having adequate blood flow to the wound as defined by Skin Perfusion Pressure (SPP) of >30mmHg recorded over intact epidermis near the open wound margin.
- Absence of clinical signs of infection (such as fever; malodorous wound exudate; increasing wound pain, drainage, erythema, friable granulation tissue and or edema).
- Participant agrees to participate in follow-up evaluations.
- Participant must be able to read and understand informed consent, and signs the informed consent.
- Less than 18 years of age.
- Pregnant or lactating woman.
- Have undergone treatment with systemic corticosteroid or immunosuppressive therapy in the past 2 months.
- Currently undergoing dialysis for renal failure.
- Subject has wounds resulting from electrical burn, arterial insufficiency, chemical or radiation insult.
- Subject has wounds with exposed bone, ligament, nerve, artery and/or tendon.
- Active or previous (within 60 days prior to the study screening visit) chemotherapy.
- Active or previous (within 60 days prior to the study screening visit) radiation to the affected wound area to be treated by study device or standard of care.
- Physical or mental disability or geographical concerns (residence not within reasonable travel distance) that would hamper compliance with required study visits.
- The Investigator believes that the subject will be unwilling or unable to comply with study protocol requirements, including application of bioelectric dressings, standard-of-care self-care requirements, and all study-related follow up visit requirements.
- History of infection with Human Immunodeficiency Virus or other immunodeficiency disorders.
- Heterotopic ossification underlying the wound based upon previous imaging or historical information from the subject's chart.
- Severe anemia - Hgb < 7 g/dl (males) or < 6.5 (females) or coagulopathy (INR > 1.7).
- Severe malnutrition (Albumin < 3.0 gm/dl; > 10% weight loss in preceding 6 weeks).
- Allergy to silver or zinc.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Clinical and Mechanistic Demonstration of a Bioelectric Dressing System for Non-healing Wound Management: A Phase II Randomized Trial|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
Active Comparator: Bioelectric Dressing
SOC + Bioelectric Dressing
PROCELLERA TM is an FDA-cleared bioelectrical dressing delivered in a sterile, single layer sheet consisting of a flexible polyester fabric layer containing silver and zinc, which are held in position on the polyester with a biocompatible binder.
Other Name: Bioelectric Dressing
No Intervention: SOC
Standard of Care
- Clinical Efficacy [ Time Frame: 2 years ]Assessment of the clinical efficacy of a bioelectric dressing in conjunction with standard-of-care on the healing rate of chronic soft tissue wounds compared with standard-of-care alone. In this 50-subject study, the primary endpoint for efficacy will be the rate of healing (healing trajectory) in the treatment group compared to that of the control group, during the 12-week treatment study period. It is hypothesized that a bioelectric dressing will reduce wound healing time when compared to SOC treatment, thereby accelerating wound healing trajectory.
- Dressing Efficacy [ Time Frame: 2 Years ]To demonstrate the efficacy of a bioelectric dressing in the areas of enhanced and accelerated wound healing on a clinical, histomorphological and cellular level studied through wound healing with decreased incidence of bacterial infection, decreased pain levels for chronic non healing wounds studied through standard validated pain assessment tools, and improved quality of life (QOL), using complex non-healing wounds as a model for tissue response. Secondary endpoints for efficacy will be study wound inflammatory infiltrate, bacterial load, and patient reported pain and quality of life (QOL) by means of visual acuity score (VAS) and SF-12, respectively.
- No other outcome measures [ Time Frame: No other outcome measures ]No other outcome measures
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01784887
|United States, Maryland|
|Walter Reed National Military Medical Center|
|Bethesda, Maryland, United States, 20889|