Clinical and Mechanistic Demonstration of a Bioelectric Dressing System for Non-healing Wound Management: A Phase II Trial
| Status: | Terminated |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 6/1/2017 |
| Start Date: | January 2013 |
| End Date: | March 2015 |
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.
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.
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.
We found this trial at
1
site
8901 Rockville Pike
Bethesda, Maryland 20889
Bethesda, Maryland 20889
(301) 295-4000
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
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