Wounds Clinical Trial - Comparative Effectiveness Study of MIST Therapy

Status Withdrawn

Clinical 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.

Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Wounds

Clinical Trial Details

NCT number	NCT01200563
Study type	Interventional
Source	Celleration, Inc.
Contact
Status	Withdrawn
Phase	Phase 4
Start date	August 2010
Completion date	July 2011

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Comparative Effectiveness Study of MIST Therapy Versus Negative Pressure Wound Therapy

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms