Trauma-related WoundNCT04079998
Procellera® Compared to Standard of Care Treatment in Mitigating Biofilm Formation in Acute Trauma and Burn Wounds
A study testing Procellera® in people with Trauma-related Wound and Burn, Partial Thickness, run by The Metis Foundation at 1 site in United States.
Trial summary
The objective of the study is to evaluate Procellera® , a novel FDA approved antimicrobial wound dressing in a prospective, randomized, controlled clinical study. The hypothesis is that when the dressing is moistened, the low electric field created by moisture-activated elemental silver and zinc electro-couple will… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Trauma-related Wound, Burn, Partial Thickness
- What is being tested?
- Procellera®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2019to 3 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years of age
- Willing and able to provide informed consent
- Participant has acute partial-thickness or full-thickness wounds caused by trauma or partial-thickness burns that are ≥ 300 cm2 in size in one contiguous area or two separate wound sites ≥ 150 cm2 each
Who cannot join
- Pregnancy
- Prisoner
- Active malignancy or immunosuppressive therapy
- Current systemic steroid use
- Known allergy or sensitivity to silver or zinc
- Participant's proposed study wound site has any of the following conditions:
Show all 10Show fewer
- Location is on the hands, face or feet
- Full-thickness burn wounds
- Exposure of visceral organs
- Exposure of hardware or prosthetic exposure
Trial locations and contacts
1 site in 1 country.
United States1 site
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
About this study
Official title: A Prospective, Randomized, Controlled Study to Determine the Superiority of a Fabric-based Wireless Electroceutical Dressing, Procellera® Compared to Standard of Care Treatment in Mitigating Biofilm Formation in Acute Trauma and Burn Wounds
The objective of the study is to evaluate Procellera® , a novel FDA approved antimicrobial wound dressing in a prospective, randomized, controlled clinical study. The hypothesis is that when the dressing is moistened, the low electric field created by moisture-activated elemental silver and zinc electro-couple will prevent formation of biofilm in wounds or to disrupt existing biofilm.
Read the detailed description
The healing of traumatic wounds, to include burns, can be compromised by the presence of infection so efforts are made to prevent or diagnose infection early in order to mitigate the negative impact on healing. Electric stimulation has previously been shown to have both bacteriostatic and bactericidal effects in wounds. Until now, administering low intensity electric field/micro-current as a therapy to mitigate biofilm infection and to improve wound healing was not feasible. In this study the investigators will use Procellera® , a FDA approved fabric based wireless electroceutical dressing (WED) consisting of a silver-zinc electro-couple for the prevention of wound biofilm formation. The dressing generates a low electric field (~1V) upon activation by a moist environment, which mitigates biofilm formation and promotes wound healing. The objectives of the study are to evaluate the efficacy of a wireless electroceutical dressing to prevent the formation or disrupting existing biofilms. The investigators will conduct a prospective, randomized controlled clinical trial using the Procellera® dressing compared to the standard of care. Treatment sites will be randomized to either receiving Procellera® or the standard of care treatment. Objective measurements and assessments will be completed during subject follow-up visits for up to one month post treatment. This includes biopsies to calculate bacterial load by assessing colony forming unit (CFU) count and bacterial film visualization using scanning electron microscopy, histology, clinical assessment of infection, Transepidermal Water Loss (TEWL) and wound photography.
- Conditions
- Trauma-related Wound, Burn, Partial Thickness
- Being tested
- Procellera®, Standard of Care
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procellera®Device
Application of Procellera® dressing.
Standard of CareOther
Application of standard of care dressings as prescribed.
| Study group | Role | What they receive |
|---|---|---|
| Procellera® dressing | Experimental | The Procellera® dressing will be applied to the wound site after standard of care cleaning and debridement. The dressing will be maintained according to the manufacturer's instructions for use. Receives: Device: Procellera® |
| Standard of Care | Active comparator | The Standard of care as prescribed will be followed for the dressing application for the wound site. Dressings will be applied to the wound site after standard of care cleaning and debridement. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of biofilm
Presence of biofilm will be assessed by obtaining a wound biopsy and analyzing with Scanning Electron Microscopy.
Measured: Day seven
Rate of eradication of biofilm production
Presence of biofilm will be assessed by obtaining a wound biopsy and analyzing with Scanning Electron Microscopy.
Measured: Day 7
Secondary outcomes (5)
Incidence of infection
Wounds will be assessed for the presence of clinical evidence indicating infection.
Measured: Day 0-30
Percent epithelialization
The percentage of epitheliazation will be assessed utilizing clinical assessments and the Silhouette Star wound camera.
Measured: Day 7
Quality of healing
Quality of healing post-epithelialization as measured by the validated Patient Observer Scar Assessment Scale (POSAS)
Measured: Day 30
Quantitative bacterial load calculation
Quantitative bacterial load will be assessed by obtaining a wound biopsy and analyzed by performing colony forming unit counts
Measured: Day 7
Incidence of adverse events
The incidence of adverse events will be reported to assess safety.
Measured: Day 0-30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start28 Feb 2019
- Primary completion13 Nov 2020
- Study completion3 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Trauma-related WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will have two wound sites that will be randomized to receive either the standard of care treatment or the Procellera® (electroceutical) dressing.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Metis Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04079998
- Sponsor's protocol ID
- C.2018.065
- Status last verified
- Jan 2021
- First submitted
- 27 Mar 2019
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Chan RK, Nuutila K, Mathew-Steiner SS, Diaz V, Anselmo K, Batchinsky M, Carlsson A, Ghosh N, Sen CK, Roy S. A Prospective, Randomized, Controlled Study to Evaluate the Effectiveness of a Fabric-Based Wireless Electroceutical Dressing Compared to Standard-of-Care Treatment Against Acute Trauma and Burn Wound Biofilm Infection. Adv Wound Care (New Rochelle). 2024 Jan;13(1):1-13. doi: 10.1089/wound.2023.0007. Epub 2023 Apr 11.
PubMed 36855334
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Study to Determine the Superiority of a Fabric-based Wireless Electroceutical Dressing, Procellera® Compared to Standard of Care Treatment in Mitigating Biofilm Formation in Acute Trauma and Burn Wounds
- ClinicalTrials.gov ID
- NCT04079998
- Acronym / sponsor ID
- C.2018.065
- Conditions
- Trauma-related Wound, Burn, Partial Thickness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- The Metis FoundationUniversity, hospital or other
- Collaborators
- Indiana University
- Study start
- 28 Feb 2019 (actual)
- Primary completion
- 13 Nov 2020 (actual)
- Study completion
- 3 Dec 2020 (actual)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to evaluate Procellera® , a novel FDA approved antimicrobial wound dressing in a prospective, randomized, controlled clinical study. The hypothesis is that when the dressing is moistened, the low electric field created by moisture-activated elemental silver and zinc electro-couple will prevent formation of biofilm in wounds or to disrupt existing biofilm.
Detailed description
The healing of traumatic wounds, to include burns, can be compromised by the presence of infection so efforts are made to prevent or diagnose infection early in order to mitigate the negative impact on healing. Electric stimulation has previously been shown to have both bacteriostatic and bactericidal effects in wounds. Until now, administering low intensity electric field/micro-current as a therapy to mitigate biofilm infection and to improve wound healing was not feasible. In this study the investigators will use Procellera® , a FDA approved fabric based wireless electroceutical dressing (WED) consisting of a silver-zinc electro-couple for the prevention of wound biofilm formation. The dressing generates a low electric field (~1V) upon activation by a moist environment, which mitigates biofilm formation and promotes wound healing. The objectives of the study are to evaluate the efficacy of a wireless electroceutical dressing to prevent the formation or disrupting existing biofilms. The investigators will conduct a prospective, randomized controlled clinical trial using the Procellera® dressing compared to the standard of care. Treatment sites will be randomized to either receiving Procellera® or the standard of care treatment. Objective measurements and assessments will be completed during subject follow-up visits for up to one month post treatment. This includes biopsies to calculate bacterial load by assessing colony forming unit (CFU) count and bacterial film visualization using scanning electron microscopy, histology, clinical assessment of infection, Transepidermal Water Loss (TEWL) and wound photography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will have two wound sites that will be randomized to receive either the standard of care treatment or the Procellera® (electroceutical) dressing.
| Arm | Type | Receives |
|---|---|---|
| Procellera® dressing | Experimental | Device: Procellera®The Procellera® dressing will be applied to the wound site after standard of care cleaning and debridement. The dressing will be maintained according to the manufacturer's instructions for use. |
| Standard of Care | Active comparator | Other: Standard of CareThe Standard of care as prescribed will be followed for the dressing application for the wound site. Dressings will be applied to the wound site after standard of care cleaning and debridement. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-65 years of age
- Willing and able to provide informed consent
- Participant has acute partial-thickness or full-thickness wounds caused by trauma or partial-thickness burns that are ≥ 300 cm2 in size in one contiguous area or two separate wound sites ≥ 150 cm2 each
Key exclusion criteria (10 listed)
- Pregnancy
- Prisoner
- Active malignancy or immunosuppressive therapy
- Current systemic steroid use
- Known allergy or sensitivity to silver or zinc
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Procellera®Application of Procellera® dressing. | Device | Procellera® dressing |
| Standard of CareApplication of standard of care dressings as prescribed. | Other | Standard of Care |
Primary outcome
Presence of biofilm
Time frame: Day seven
Presence of biofilm will be assessed by obtaining a wound biopsy and analyzing with Scanning Electron Microscopy.
Rate of eradication of biofilm production
Time frame: Day 7
Presence of biofilm will be assessed by obtaining a wound biopsy and analyzing with Scanning Electron Microscopy.
5 secondary outcomes
Incidence of infection
Time frame: Day 0-30
Percent epithelialization
Time frame: Day 7
Quality of healing
Time frame: Day 30
Quantitative bacterial load calculation
Time frame: Day 7
Incidence of adverse events
Time frame: Day 0-30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Derived from this study: PubMed 36855334Chan RK, Nuutila K, Mathew-Steiner SS, Diaz V, Anselmo K, Batchinsky M, Carlsson A, Ghosh N, Sen CK, Roy S. A Prospective, Randomized, Controlled Study to Evaluate the Effectiveness of a Fabric-Based Wireless Electroceutical Dressing Compared to Standard-of-Care Treatment Against Acute Trauma and Burn Wound Biofilm Infection. Adv Wound Care (New Rochelle). 2024 Jan;13(1):1-13. doi: 10.1089/wound.2023.0007. Epub 2023 Apr 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procellera® in people with Trauma-related Wound and Burn, Partial Thickness, run by The Metis Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of biofilm (time frame: Day seven). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04079998, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.