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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

Tracking Information
First Submitted Date  ICMJE February 4, 2013
First Posted Date  ICMJE February 6, 2013
Last Update Posted Date May 31, 2017
Study Start Date  ICMJE January 2013
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01784887 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2013)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 5, 2013)
No other outcome measures [ Time Frame: No other outcome measures ]
No other outcome measures
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Clinical and Mechanistic Demonstration of a Bioelectric Dressing System for Non-healing Wound Management: A Phase II Trial
Official Title  ICMJE Clinical and Mechanistic Demonstration of a Bioelectric Dressing System for Non-healing Wound Management: A Phase II Randomized Trial
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Non-healing Soft Tissue Wounds
Intervention  ICMJE 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
Study Arms  ICMJE
  • Active Comparator: Bioelectric Dressing
    SOC + Bioelectric Dressing
    Intervention: Drug: Procellera
  • No Intervention: SOC
    Standard of Care
Publications * Blount AL, Foster S, Rapp DA, Wilcox R. The use of bioelectric dressings in skin graft harvest sites: a prospective case series. J Burn Care Res. 2012 May-Jun;33(3):354-7. doi: 10.1097/BCR.0b013e31823356e4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 21, 2014)
2
Original Estimated Enrollment  ICMJE
 (submitted: February 5, 2013)
60
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01784887
Other Study ID Numbers  ICMJE 370421
I-11-38 ( Other Grant/Funding Number: AFMSA )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: no data
Responsible Party Henry M. Jackson Foundation for the Advancement of Military Medicine
Study Sponsor  ICMJE Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Henry M. Jackson Foundation for the Advancement of Military Medicine
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP