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Comparative Effectiveness Study of MIST Therapy Versus Negative Pressure Wound Therapy

Primary Purpose

Wounds

Status

Withdrawn

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

MIST Therapy

Vacuum Assisted Closure

MIST Therapy and Negative Pressure Wound Therapy

About this trial

This is an interventional treatment trial for Wounds focused on measuring MIST Therapy, Negative Pressure Wound Therapy, Wound care in long-term acute care hospital, Wound care in skilled nursing facility setting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
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

Exclusion Criteria:

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
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

Sites / Locations

Trillium Specialty Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Group 1

Group 2

Group 3

Arm Description

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.

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.

Subjects assigned to this group will receive MIST Therapy treatments and Negative Pressure Wound Therapy.

Outcomes

Primary Outcome Measures

Rate of wound healing.

Determined by the change in wound surface area/volume from the initial evaluation date to study end.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01200563

First Posted

September 10, 2010

Last Updated

December 11, 2014

Sponsor

Celleration, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01200563

Brief Title

Comparative Effectiveness Study of MIST Therapy Versus Negative Pressure Wound Therapy

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Withdrawn

Why Stopped

Study site compliance

Study Start Date

August 2010 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Celleration, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Wounds

Keywords

MIST Therapy, Negative Pressure Wound Therapy, Wound care in long-term acute care hospital, Wound care in skilled nursing facility setting

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Active Comparator

Arm Description

Arm Title

Group 2

Arm Type

Active Comparator

Arm Description

Arm Title

Group 3

Arm Type

Active Comparator

Arm Description

Subjects assigned to this group will receive MIST Therapy treatments and Negative Pressure Wound Therapy.

Intervention Type

Device

Intervention Name(s)

MIST Therapy

Other Intervention Name(s)

MIST

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Vacuum Assisted Closure

Other Intervention Name(s)

VAC Therapy

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

MIST Therapy and Negative Pressure Wound Therapy

Other Intervention Name(s)

MIST, VAC Therapy

Intervention Description

MIST Therapy will be provided 3 times per week, NPWT will be provided according to the manufacturer's recommended guidelines.

Primary Outcome Measure Information:

Title

Rate of wound healing.

Description

Determined by the change in wound surface area/volume from the initial evaluation date to study end.

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Change wound exudation levels.

Description

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.

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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 Exclusion Criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kenneth O Anaeme, MD

Organizational Affiliation

Trillium Specialty Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Trillium Specialty Hospital

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85206

Country

United States

12. IPD Sharing Statement

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Comparative Effectiveness Study of MIST Therapy Versus Negative Pressure Wound Therapy

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