Comparative Effectiveness Study of MIST Therapy Versus Negative Pressure Wound Therapy

NCT01200563 | Withdrawn Phase 4

• 1 other identifier: CR-86000
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Wounds

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Rate of wound healing.

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

  6 weeks

Secondary Outcomes (1)

• Change wound exudation levels.

  6 weeks

Study Arms (3)

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.

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.

Device: Vacuum Assisted Closure

Group 3

ACTIVE COMPARATOR

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

Device: MIST Therapy and Negative Pressure Wound Therapy

Interventions

MIST Therapy DEVICE

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.

Also known as: MIST

Group 1

Vacuum Assisted Closure DEVICE

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.

Also known as: VAC Therapy

Group 2

MIST Therapy and Negative Pressure Wound Therapy DEVICE

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

Also known as: MIST, VAC Therapy

Group 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Celleration, Inc.: lead

Study Sites (1)

Trillium Specialty Hospital

Mesa, Arizona, 85206, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Negative-Pressure Wound Therapy

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Study Officials

• Kenneth O Anaeme, MD

  Trillium Specialty Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2010
• First Posted: September 13, 2010
• Study Start: August 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: December 15, 2014

Record last verified: 2014-12

Locations

US (1)