Split Thickness Donor Site Pilot Study
| Status: | Archived |
|---|---|
| Conditions: | Other Indications, Cardiology, Hospital, Gastrointestinal |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Gastroenterology, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | October 2010 |
| End Date: | February 2011 |
A Prospective, Randomized, Controlled Pilot Study of the MIST Therapy System for the Treatment of Split Thickness Donor Sites
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 pilot
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.
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 on post-op days 3 and 5 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.
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