WoundsPhase 4NCT01200563
Comparative Effectiveness Study of MIST Therapy Versus Negative Pressure Wound Therapy
A Phase 4 study testing MIST Therapy, Vacuum Assisted Closure and MIST Therapy and Negative Pressure Wound Therapy in people with Wounds, run by Celleration, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the clinical and economic effectiveness of MIST Therapy vs NPWT vs MIST Therapy in conjunction with NPWT in the treatment of full thickness wounds presenting in the LTACH and SNF settings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounds
- What is being tested?
- MIST Therapy, Vacuum Assisted Closure and MIST Therapy and Negative Pressure Wound Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Jul 2011
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subject of any race and at least 18 years old
- Subject presents with full thickness wound of any etiology
- Subject's wound is between 20cm2 and 250cm2
- Subject's wound has less that 20% necrotic tissue
- Subject is nutritionally stable and/or taking nutritional supplements and is being followed by a dietician
- Subject or subject's legally authorized representative understands the nature of the study procedure(s) and provides written informed consent prior to study enrollment
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- Women of childbearing potential must not be pregnant or lactating, and must be using adequate and accepted contraceptive methods
- Subject has a reasonable expectation of completing the study
- Subject has had no prior MIST Therapy or Negative Pressure Wound Therapy to the enrolled wound
Who cannot join
- Subject's condition requires the use of topical antibiotics at the time of study enrollment
- Subject's wound would require ultrasound near an electronic implant or prosthesis, e.g., near or over the heart, or over the thoracic area if the patient is using a cardiac pacemaker
- Subject is known to be suffering from a disorder or other situation that the subject or investigator feels would interfere with compliance or other study requirements
- Subject is currently enrolled or has been enrolled in the last 30 days in another investigational device or drug trial
- Subject has a combination of medical condition(s) that in the opinion of the investigator would make the subject an inappropriate candidate for the study, i.e., diabetes, including renal, hepatic, hematologic, neurologic, or immune disease
- Subject's wound is not appropriate for Negative Pressure Wound Therapy or MIST Therapy
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- Subject has osteomyelitis, systemic sepsis, or an infection not related to his/her index wound (e.g., UTI, pulmonary) that has been untreated or has not been appropriately managed
- Subject has a fistula(s) to the index wound bed
- Subject's index wound is a head or neck wound
- Subject's index wound presents with a malignancy in the wound bed
- Subject's anticoagulation therapy is unstable
- Subject is undergoing chemotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative, Prospective, Randomized Study of MIST Therapy vs NPWT vs MIST Therapy in Conjunction With NPWT on the Rate of Healing and Its Economic Value in the Treatment of Full Thickness Wounds in a LTACH and SNF
The purpose of this study is to evaluate the clinical and economic effectiveness of MIST Therapy vs NPWT vs MIST Therapy in conjunction with NPWT in the treatment of full thickness wounds presenting in the LTACH and SNF settings.
Read the detailed description
A comparative, prospective, randomized study.
Study objectives: Comparison between study groups of the assigned study treatment's effect on the rate of wound healing, cost per episode of care, severity of wound pain, and the occurrence of adverse events.
Subject recruitment: Consecutive, prospective subjects admitted to the study site will be screened for study enrollment and potential randomization. Prospective data will be collected on study subjects until at least 10 subjects are randomized into each of three treatment groups: MIST Therapy; NPWT; or MIST Therapy and NPWT.
Protocol and procedures: All randomized subjects will continue to receive standard of care treatment appropriate for their wound for the duration of their study treatment regardless of their assigned treatment group. Subjects will continue to receive assigned study treatment as long as their wound continues to show improvement, as determined by the investigator. Study treatment will continue until wound closure, or for up to 6 weeks without wound closure. A baseline evaluation will include a medical history assessment, VAS pain score, wound history and evaluation including: wound dimension measurements, overall wound assessment, digital photography, and appropriate sharp debridement, if necessary. Weekly wound assessments will include a wound evaluation, digital photography and VAS pain score. Prospective data will also be collected on specific wound care supplies and interventions provided. These data will be tracked as interventions occur while the wound continues to be treated with the assigned study treatment. Economic data will include type, quantity, duration, associated frequency, and professional time requirements.
- Conditions
- Wounds
- Being tested
- MIST Therapy, Vacuum Assisted Closure, MIST Therapy and Negative Pressure Wound Therapy
- Keywords
- MIST Therapy, Negative Pressure Wound Therapy, Wound care in long-term acute care hospital, Wound care in skilled nursing facility setting
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIST TherapyDevice
Also called MIST
Low-frequency, non-contact ultrasound system delivering therapeutic ultrasound via a fine saline mist to the wound bed without direct contact of the device with the body.
Vacuum Assisted ClosureDevice
Also called VAC Therapy
Controlled negative pressure (vacuum) delivering negative (sub-atmospheric) pressure to the wound site applied by a tubing which decompresses a foam dressing, continuously or intermittently depending on wound type.
MIST Therapy and Negative Pressure Wound TherapyDevice
Also called MIST, VAC Therapy
MIST Therapy will be provided 3 times per week, NPWT will be provided according to the manufacturer's recommended guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Subjects assigned to receive MIST Therapy will be treated 3 times per week. The duration of each MIST treatment will be dependent on the wound's area measured at baseline and at each weekly assessment. Receives: Device: MIST Therapy |
| Group 2 | Active comparator | Subjects assigned to receive Negative Pressure Wound Therapy will be treated with the Vacuum Assisted Closure system. For administration of this study treatment, e.g., treatment cycle, target pressure and dressing changes, the manufacturer's recommended guidelines will be followed. Receives: Device: Vacuum Assisted Closure |
| Group 3 | Active comparator | Subjects assigned to this group will receive MIST Therapy treatments and Negative Pressure Wound Therapy. Receives: Device: MIST Therapy and Negative Pressure Wound Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of wound healing.
Determined by the change in wound surface area/volume from the initial evaluation date to study end.
Measured: 6 weeks
Secondary outcomes (1)
Change wound exudation levels.
Determined by the change in amount of exudates recorded using a scale of none, mild, moderate, and heavy, from the initial evaluation date to study end.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionJul 2011
- Study completionJul 2011
Why it stopped: Study site compliance
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celleration, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kenneth O Anaeme, MD, Principal investigator, Trillium Specialty Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01200563
- Sponsor's protocol ID
- CR-86000
- Status last verified
- Dec 2014
- First submitted
- 10 Sep 2010
- Last updated
- 15 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative, Prospective, Randomized Study of MIST Therapy vs NPWT vs MIST Therapy in Conjunction With NPWT on the Rate of Healing and Its Economic Value in the Treatment of Full Thickness Wounds in a LTACH and SNF
- ClinicalTrials.gov ID
- NCT01200563
- Acronym / sponsor ID
- CR-86000
- Conditions
- Wounds
- Keywords
- MIST Therapy, Negative Pressure Wound Therapy, Wound care in long-term acute care hospital, Wound care in skilled nursing facility setting
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study site compliance
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Celleration, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 13 Sep 2010 (estimated)
- 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 purpose of this study is to evaluate the clinical and economic effectiveness of MIST Therapy vs NPWT vs MIST Therapy in conjunction with NPWT in the treatment of full thickness wounds presenting in the LTACH and SNF settings.
Detailed description
A comparative, prospective, randomized study.
Study objectives: Comparison between study groups of the assigned study treatment's effect on the rate of wound healing, cost per episode of care, severity of wound pain, and the occurrence of adverse events.
Subject recruitment: Consecutive, prospective subjects admitted to the study site will be screened for study enrollment and potential randomization. Prospective data will be collected on study subjects until at least 10 subjects are randomized into each of three treatment groups: MIST Therapy; NPWT; or MIST Therapy and NPWT.
Protocol and procedures: All randomized subjects will continue to receive standard of care treatment appropriate for their wound for the duration of their study treatment regardless of their assigned treatment group. Subjects will continue to receive assigned study treatment as long as their wound continues to show improvement, as determined by the investigator. Study treatment will continue until wound closure, or for up to 6 weeks without wound closure. A baseline evaluation will include a medical history assessment, VAS pain score, wound history and evaluation including: wound dimension measurements, overall wound assessment, digital photography, and appropriate sharp debridement, if necessary. Weekly wound assessments will include a wound evaluation, digital photography and VAS pain score. Prospective data will also be collected on specific wound care supplies and interventions provided. These data will be tracked as interventions occur while the wound continues to be treated with the assigned study treatment. Economic data will include type, quantity, duration, associated frequency, and professional time requirements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Device: MIST TherapySubjects assigned to receive MIST Therapy will be treated 3 times per week. The duration of each MIST treatment will be dependent on the wound's area measured at baseline and at each weekly assessment. |
| Group 2 | Active comparator | Device: Vacuum Assisted ClosureSubjects assigned to receive Negative Pressure Wound Therapy will be treated with the Vacuum Assisted Closure system. For administration of this study treatment, e.g., treatment cycle, target pressure and dressing changes, the manufacturer's recommended guidelines will be followed. |
| Group 3 | Active comparator | Device: MIST Therapy and Negative Pressure Wound TherapySubjects assigned to this group will receive MIST Therapy treatments and Negative Pressure Wound Therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female subject of any race and at least 18 years old
- Subject presents with full thickness wound of any etiology
- Subject's wound is between 20cm2 and 250cm2
- Subject's wound has less that 20% necrotic tissue
- Subject is nutritionally stable and/or taking nutritional supplements and is being followed by a dietician
Key exclusion criteria (12 listed)
- Subject's condition requires the use of topical antibiotics at the time of study enrollment
- Subject's wound would require ultrasound near an electronic implant or prosthesis, e.g., near or over the heart, or over the thoracic area if the patient is using a cardiac pacemaker
- Subject is known to be suffering from a disorder or other situation that the subject or investigator feels would interfere with compliance or other study requirements
- Subject is currently enrolled or has been enrolled in the last 30 days in another investigational device or drug trial
- Subject has a combination of medical condition(s) that in the opinion of the investigator would make the subject an inappropriate candidate for the study, i.e., diabetes, including renal, hepatic, hematologic, neurologic, or immune disease
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 |
|---|---|---|
| MIST TherapyAlso: MISTLow-frequency, non-contact ultrasound system delivering therapeutic ultrasound via a fine saline mist to the wound bed without direct contact of the device with the body. | Device | Group 1 |
| Vacuum Assisted ClosureAlso: VAC TherapyControlled negative pressure (vacuum) delivering negative (sub-atmospheric) pressure to the wound site applied by a tubing which decompresses a foam dressing, continuously or intermittently depending on wound type. | Device | Group 2 |
| MIST Therapy and Negative Pressure Wound TherapyAlso: MIST, VAC TherapyMIST Therapy will be provided 3 times per week, NPWT will be provided according to the manufacturer's recommended guidelines. | Device | Group 3 |
Primary outcome
Rate of wound healing.
Time frame: 6 weeks
Determined by the change in wound surface area/volume from the initial evaluation date to study end.
1 secondary outcome
Change wound exudation levels.
Time frame: 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2014.
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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.
Kenneth O Anaeme, MD principal investigator
Trillium Specialty Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MIST Therapy, Vacuum Assisted Closure and MIST Therapy and Negative Pressure Wound Therapy in people with Wounds, run by Celleration, Inc. 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 9 inclusion and 12 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: withdrawn, as of the sponsor's last update on 15 Dec 2014. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Rate of wound healing. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Dec 2014.