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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
Sponsor:
Information provided by (Responsible Party):
Henry M. Jackson Foundation for the Advancement of Military Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Non-healing Soft Tissue Wounds Drug: Procellera Phase 1 Phase 2

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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

  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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Bioelectric Dressing
SOC + Bioelectric Dressing
Drug: Procellera
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. No other outcome measures [ Time Frame: No other outcome measures ]
    No other outcome measures



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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United States, Maryland
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
Sponsors and Collaborators
Henry M. Jackson Foundation for the Advancement of Military Medicine

Additional Information:
Publications:
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Responsible Party: Henry M. Jackson Foundation for the Advancement of Military Medicine
ClinicalTrials.gov Identifier: NCT01784887     History of Changes
Other Study ID Numbers: 370421
I-11-38 ( Other Grant/Funding Number: AFMSA )
First Posted: February 6, 2013    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no data
Additional relevant MeSH terms:
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Wounds and Injuries