Chronic Nonhealing Wounds Clinical Trial
Official title:
A Prospective, Randomized, Controlled Study of MIST Therapy's Effectiveness in Wound Bed Preparation and the Role of Bacterial Biofilm in Subjects Presenting With Chronic, Non-healing Wounds
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 that 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 an investigator-initiated prospective, randomized, controlled
single blinded study, at a single study center, of persons presenting with a chronic,
non-healing wound 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 subjects 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 using a Sham device (control
group). The Sham device is a nebulizer compressor designed to deliver a continuous saline
mist to a MIST Therapy System, but without the ultrasound waves. Both groups will have a
primary closure (ie. split thickness skin graft or delayed primary closure) as part of the
eventual treatment plan. Both groups will undergo up to 5 SOC surgical debridements in the
OR setting, with each debridement immediately followed by the subject's assigned study
treatment.
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 the Georgetown
University lab for quantitative analysis of the bacteria present.
Following the Baseline evaluation and surgical debridement, study subjects will undergo up
to 4 subsequent Interim Study Evaluations. The Interim Study Evaluations will include a
wound assessment, wound measurements, digital photographs, and an adverse event assessment,
and will be conducted at a frequency determined appropriate by the Principal Investigator
until the wound bed appears appropriate for primary closure. As part of each Interim Study
Evaluation, study subjects will undergo a subsequent surgical debridement in the OR setting,
immediately followed by the assigned study treatment, (i.e., sham device with saline rinse
or MIST therapy). Prior to each subsequent surgical debridement, a SOC wound culture and
quantitative wound culture will be obtained for analysis.
Final tissue biopsies, from the wound center and wound margin, will be obtained prior to the
primary closure procedure. Following definitive wound closure procedure, split thickness
skin graft or delayed primary wound closure, the subject will undergo Bi-Monthly Wound
Assessment, being followed for a maximum of 20 weeks from the date of his/her first surgical
debridement. A Bi-Monthly Wound Assessment will include an assessment of maintained wound
closure and an adverse event assessment.
SOC post-operative dressings may include Moist Wound Therapy and the use of Negative
Pressure Wound Therapy. 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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00545896 -
Extracorporeal Shockwave Treatment for Chronic Soft Tissue Wounds
|
Phase 2 |