Clinical trial NCT01214980: Split Thickness Donor Site Healing With MIST Study
Official title: A Prospective, Randomized, Controlled Pilot Study of the MIST Therapy System for the Treatment of Split Thickness Donor Sites
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns
Trauma
Venous Ulcers
Keywords: Low-frequency ultrasound
Wound healing
Split thickness wound healing
Skin graft donor site healing
Lead sponsor: Celleration, Inc.
Sponsor class: INDUSTRY
First posted: 2010-10-05
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of Wound Healing
timeFrame: Days to absence of drainage from the initial donor site harvest procedure
Secondary outcomes:
measure: Time to Full Epithelialization
timeFrame: Days to full epithelialization
measure: Numeric Pain Score
timeFrame: 5 weeks
measure: Numeric Itching Score
timeFrame: 5 weeks
measure: Donor Site Recidivism Rate
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
Study officials:
affiliation: James A. Haley Veterans Hospital
name: Lisa J Gould, M.D.,Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: University South Florida
name: David Smith, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.