Clinical and Mechanistic Demonstration of a Bioelectric Dressing System for Non-healing Wound Management: A Phase II Trial

Clinical and Mechanistic Demonstration of a Bioelectric Dressing System for Non-healing Wound Management: A Phase II Randomized Trial

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.

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

1. Inclusion 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.

2. Exclusion Criteria

   • 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.

Inclusion 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.

Exclusion Criteria:

• 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.