A Prospective, Randomized, Controlled Pilot Study of the MIST Therapy System for the Treatment of Split Thickness Donor Sites
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Celleration, Inc.
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Rate of Wound Healing
Study Overview
Brief Summary
Subjects requiring skin grafting due to burns, trauma, or chronic venous ulcers with split thickness donor sites expected to be between 20 and 200 square cm will be consecutively screened for study eligibility. This study is a prospective, randomized, controlled trial evaluating effect of MIST Therapy on the healing of split thickness skin graft donor sites compared to standard care. Subjects meeting all eligibility criteria and providing appropriate written informed consent will be enrolled for study participation.
Detailed Description
Enrolled subjects will be randomized to receive one of two treatment courses: a) MIST Therapy in conjunction with standard of care (SOC) (treatment group); or b)SOC alone (control group).
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female subject of any race and at least 18 years old
- •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 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 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
Arms & Interventions
Control arm
Standard of care treatment
Intervention: Standard of care (Other)
MIST Therapy in conjunction with SOC
Low-frequency, non-contact ultrasound administered in conjunction with standard of care treatment
Intervention: MIST Therapy (Device)
Outcomes
Primary Outcomes
Rate of Wound Healing
Time Frame: Days to absence of drainage from the initial donor site harvest procedure
The primary endpoint is an average of the group for each participant's donor site wound closure time, defined as days to absence of drainage from the date of the initial donor site harvest procedure.
Secondary Outcomes
- Numeric Itching Score(5 weeks)
- Time to Full Epithelialization(Days to full epithelialization)
- Numeric Pain Score(5 weeks)
- Donor Site Recidivism Rate(6 weeks)