Split Thickness Donor Site Healing With MIST Study
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective, Randomized, Controlled Pilot Study of the MIST Therapy System for the Treatment of Split Thickness Donor Sites|
- Rate of wound healing [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]The primary endpoint will be determined by the time to wound closure from the date of each subject's initial donor site harvest procedure.
- Cellular and molecular changes in the wound bed [ Time Frame: 5 days ] [ Designated as safety issue: No ]The secondary endpoint will be evaluated by molecular protein analysis including: proinflammatory cytokine mediators, inflammatory chemokine mediators, tissue reparative and remodeling mediators (MMPs and TIMPs)
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||July 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Experimental: MIST Therapy in conjunction with SOC
Low-frequency, non-contact ultrasound administered in conjunction with standard of care treatment
Device: MIST Therapy
Low-frequency, non-contact ultrasound therapy provided in conjunction with standard of care treatment on a daily basis for 5 days.
Active Comparator: Control arm
Standard of care treatment
Other: Standard of care
Standard of care provided per site-specific protocol
Other Name: Standard wound care
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.
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.
|United States, Florida|
|Tampa General Hospital|
|Tampa, Florida, United States, 33606|
|Principal Investigator:||Lisa J Gould, M.D.,Ph.D||James A. Haley Veterans Hospital|
|Principal Investigator:||David Smith, MD||University South Florida|