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The purpose of this study is to evaluate the effectiveness of MIST Therapy in combination with standard of care (SOC) compared to SOC alone on reducing the bacteria in your wound and preparing the wound bed for surgical closure in patients who are diagnosed with end-stage renal disease (ESRD) and have chronic, non-healing wounds.
The MIST Therapy System delivers therapeutic ultrasound to the wound bed without direct contact. Saline solution is converted into fine particles and released towards the wound by sound pressure waves to remove dead or damaged tissue. The MIST Therapy System is currently the only FDA cleared non-contact ultrasound device to promote wound healing.
Standard of care procedures include surgical debridement of the wound in the operating room to remove all infected, dead tissue and bone.
This research is being done because the investigators do not know which of these commonly-used treatments is better, and because the investigators would like to evaluate the bacteria that is present in the wound.
The trial is designed as a prospective, randomized, controlled study, at a single study center, of persons with ESRD presenting with a chronic, non-healing wound below the knee with a potential for rapid deterioration, leading to limb loss. Chronic wounds defined as, having been present longer than 30 days and have failed to demonstrate greater than about a 50% reduction in surface area in the previous 30 days despite the administration of appropriate and standard wound care as well as cases presenting with acute gangrene or massive tissue loss that do not meet the 30 day criteria will be included. All wounds must be at least 5 cm2. A SOC Doppler assessment will be performed to ensure that the wound is adequately vascularized.
For patients who present with multiple chronic, non-healing wounds, only the largest wound meeting the entrance criteria will be enrolled in the study. This will be referred to as the patient's "index wound." Once a wound is designated as the "index wound," that wound will remain the index wound for the duration of the patient's study participation.
Adult patients with ESRD and who have a chronic, non-healing wound consenting to the study will be screened for eligibility and if subjects meet all the inclusion and none of the exclusion criteria, they will be enrolled for study participation. Enrolled patients will then be randomized to receive one of two treatment courses: a) MIST Therapy in conjunction with Standard of Care (SOC) (treatment group) or, b) SOC only (control group). Prior to initiating the assigned study treatment, a randomized patient will be required to undergo a Baseline Evaluation. The Baseline Evaluation will include: wound area measurement, wound bed evaluation, and digital photograph. Following the Baseline Evaluation, a study patient will undergo surgical debridement of the index wound in the operating room setting. During this time, a tissue sample will be obtained prior to debridement in both study groups. A second tissue sample will be obtained from both study groups immediately following debridement (either SOC debridement or MIST therapy, depending on which group the patient was randomized into). These tissue samples will be utilized to assess the presence of biofilm in the wound prior to and following the assigned study treatment. A tissue sample will be taken in the form of a 2mm punch biopsy that will be obtained from the center of the wound as well as the wound margin in both study groups prior to debridement and immediately following debridement (either SOC debridement or MIST therapy, depending on which group the patient was randomized into). Along with SOC wound cultures, a swab of the wound will be taken before and after the treatment at the first OR visit and be sent to a central laboratory for quantitative analysis of the bacteria present. If randomly placed in Group 1, MIST therapy will be performed by the surgeon in the operating room directly following the SOC surgical debridement.
On the third day following the initial surgical debridement, the patient will undergo an Interim Study Evaluation. If, in the opinion of the principal investigator (utilizing the results of the post debridement tissue cultures and visualization of the wound bed), the index wound does not appear appropriate for delayed primary closure or has not achieved closure, the study patient will undergo another surgical debridement, and 2mm punch biopsies will be obtained before debridement and after debridement (either SOC debridement or MIST therapy, depending on which group the patient was randomized into). Another wound swab will be obtained before each treatment in the OR and sent to the central laboratory for quantitative analysis. The index wound will be left open, receiving SOC, and monitored for another 3 days. This pattern of Interim Study Evaluation, surgical debridement, tissue samples and administration of the assigned study treatment will continue until, based on the principal investigator's subjective assessment, the index wound bed appears to be clean of bacterial load and properly prepared for delayed primary closure or wound closure has been achieved. The 2mm punch biopsies will be obtained at the 1st and, if needed, 2nd OR debridement and then a final biopsy will be performed prior to primary closure.
Patients will receive wound care treatments according to the site-specific SOC protocol, including but not limited to fluid resuscitation, pain medications, systemic antibiotics, and control of bleeding,. SOC dressing to include wound cleansing and the use of Negative Pressure Wound Therapy or moist wound therapy will be at the discretion of the principal investigator. NOTE: No impregnated dressings will be allowed during the study period. No topical antibiotics or antibiotic dressings, topical antiseptics (silver, iodine, etc.), or antimicrobials will be allowed. The use of EMLA Cream is not allowed.
Following a patient's delayed primary wound closure procedure, the patient will undergo Bi-Monthly Wound Assessment, being followed for a maximum of 20 weeks from the date of his/her first surgical debridement or for 4 weeks after wound closure.
All wound cultures and biopsies must be obtained following a specified protocol as outlined above, and must be sent to central laboratories for analysis. The results of the wound cultures and biopsies will be compared from baseline to interim to the last culture and biopsy prior to delayed primary closure to determine what effect, if any, study treatment had on the eradication of biofilm and quantitative measures of bacterial load in chronic, non-healing wounds in ESRD patients. SOC wound cultures will also be obtained intraoperatively and submitted to the GU lab for immediate analysis to aid in a faster assessment of the status of bacteria within the wound while the patient is in-house.
An Interim Study Evaluation will include a wound assessment, wound measurements, digital photographs, and an adverse event assessment. A Bi-Monthly Wound Assessment will include an assessment of maintained wound closure and an adverse event assessment. Patients will be allowed to take pain medications and utilize systemic antibiotics as needed during the study protocol; however, no topical antibiotics will be allowed in the study. Patients will be allowed into the study while actively using systemic antibiotics and can remain in the study if systemic antibiotics are clinically required later in the course of the trial.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
End-Stage Renal Disease
MIST Therapy, Standard of Care
Not yet recruiting
Published on BioPortfolio: 2014-08-27T03:13:35-0400
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