Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2012-02-29
2014-07-31
Brief Summary
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Detailed Description
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On post-op day 1, subjects will undergo a baseline evaluation prior to initiating assigned study treatment, including: wound measurement, wound bed evaluation, description of periwound skin, measurement of type and quantity of exudation, wound clinical symptoms (pain, burning, itching), and digital photography. Subject will then receive assigned study treatment.
SOC includes, but is not limited to, fluid resuscitation, pain medications, systemic antibiotics, control of bleeding, and standard dressings as appropriate for the moisture balance of the wound. SOC also includes providing a hydrocolloid border around the wound with a transparent film dressing over the donor site. No advanced or impregnated dressings are allowed during the study. No topical antibiotics or antibiotic dressings, topical antiseptics (silver, iodine, etc.,) or antimicrobials are allowed.
The transparent film will be removed each day and wound fluid will be collected for analysis. After wound fluid collection, subjects will receive their assigned study treatment. Subjects randomized to receive MIST Therapy will be treated daily for 5 consecutive days. Following administration of the assigned study treatment, subjects will have replacement of the transparent film. The hydrocolloid will remain in place on the border of intact skin.
Evaluations performed will include a wound assessment, digital photography, wound pain assessment and an adverse event assessment. Following the initial 5 day treatment, the study wounds will be dressed per SOC with dressing changes as needed.
Subjects will undergo a weekly wound assessment through 6 weeks from the date of study enrollment. A weekly wound assessment will include the assessment of maintained wound closure, digital photography, and an adverse event assessment.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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MIST Therapy in conjunction with SOC
Low-frequency, non-contact ultrasound administered in conjunction with standard of care treatment
MIST Therapy
Low-frequency, non-contact ultrasound therapy provided in conjunction with standard of care treatment on a daily basis for 5 days.
Control arm
Standard of care treatment
Standard of care
Standard of care provided per site-specific protocol
Interventions
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MIST Therapy
Low-frequency, non-contact ultrasound therapy provided in conjunction with standard of care treatment on a daily basis for 5 days.
Standard of care
Standard of care provided per site-specific protocol
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject requires skin grafting
* Subject's wound must be between 20 cm2 and 200 cm2
* Subject's wound presents with no clinical signs of acute infection
* Subject has ahd no prior MIST Therapy to the enrolled wound
* Subject or subject's legally authorized representative understands the nature of the procedure(s) and provides written informed consent prior to study enrollment
* Subject is willing and able to comply with all specified care and visit requirements
* 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
Exclusion Criteria
* 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 subject 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
18 Years
ALL
No
Sponsors
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Celleration, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Lisa J Gould, M.D.,Ph.D
Role: PRINCIPAL_INVESTIGATOR
James A. Haley Veterans Hospital
David Smith, MD
Role: PRINCIPAL_INVESTIGATOR
University South Florida
Locations
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Tampa General Hospital
Tampa, Florida, United States
Countries
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References
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Sinha S, Gabriel VA, Arora RK, Shin W, Scott J, Bharadia SK, Verly M, Rahmani WM, Nickerson DA, Fraulin FO, Chatterjee P, Ahuja RB, Biernaskie JA. Interventions for postburn pruritus. Cochrane Database Syst Rev. 2024 Jun 5;6(6):CD013468. doi: 10.1002/14651858.CD013468.pub2.
Prather JL, Tummel EK, Patel AB, Smith DJ, Gould LJ. Prospective Randomized Controlled Trial Comparing the Effects of Noncontact Low-Frequency Ultrasound with Standard Care in Healing Split-Thickness Donor Sites. J Am Coll Surg. 2015 Aug;221(2):309-18. doi: 10.1016/j.jamcollsurg.2015.02.031. Epub 2015 Mar 14.
Other Identifiers
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CR-86003
Identifier Type: -
Identifier Source: org_study_id