Split Thickness Donor Site Healing With MIST Study

• Sponsor: Celleration, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01214980
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Arms: 2
• Duration (Months): 28.9
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Burns; Trauma; Venous Ulcers	Device: MIST Therapy; Other: Standard of care	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Prospective, Randomized, Controlled Pilot Study of the MIST Therapy System for the Treatment of Split Thickness Donor Sites
• Study Start Date: Feb 1, 2012
• Actual Primary Completion Date: Jul 1, 2013
• Actual Study Completion Date: Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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.; Other Names: MIST MIST Treatment
Active Comparator: Control arm Standard of care treatment	Other: Standard of care; Standard of care provided per site-specific protocol; Other Names: Standard wound care

Outcome Measures

Primary Outcome Measures

1. Rate of Wound Healing [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 Outcome Measures

1. Time to Full Epithelialization [Days to full epithelialization]

   Time to full epithelialization in days from the date of initial donor site harvest procedure per the blinded adjudication of the donor site image.

2. Numeric Pain Score [5 weeks]

   Average donor site pain score for each treatment group, numeric scale of 0 (no pain) to 10 (worst possible pain), at five weeks post skin graft procedure

3. Numeric Itching Score [5 weeks]

   Average donor site itching score for treatment group, numeric scale 0 (no itch) to 10 (worst possible itch), at 5 weeks post skin graft procedure

4. Donor Site Recidivism Rate [6 weeks]

   Number of donor sites that healed and then reopened during the study.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tampa General Hospital	Tampa	Florida	United States	33606

Sponsors and Collaborators

• Celleration, Inc.

Investigators

• Principal Investigator: Lisa J Gould, M.D.,Ph.D, James A. Haley Veterans Hospital
• Principal Investigator: David Smith, MD, University South Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Celleration, Inc.
• ClinicalTrials.gov Identifier: NCT01214980
• Other Study ID Numbers: CR-86003
• First Posted: Oct 5, 2010
• Last Update Posted: Dec 19, 2014
• Last Verified: Dec 1, 2014

• Keywords provided by Celleration, Inc.: Low-frequency ultrasound; Wound healing; Split thickness wound healing; Skin graft donor site healing
• Additional relevant MeSH terms: Varicose Ulcer

Study Results

Participant Flow

Arm/Group Title	MIST Therapy in Conjunction With Standard Care	Control Arm
Arm/Group Description	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 (Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma) on a daily basis for 5 days.	Standard of care treatment Standard of care: Standard of care provided per site-specific protocol Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma
Period Title: Overall Study
STARTED	16	16
COMPLETED	13	14
NOT COMPLETED	3	2

Baseline Characteristics

Arm/Group Title	MIST Therapy in Conjunction With Standard Care	Control Arm	Total
Arm/Group Description	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 (Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma) on a daily basis for 5 days.	Standard of care treatment Standard of care: Standard of care provided per site-specific protocol Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma	Total of all reporting groups
Overall Participants	16	16	32
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	32	54	49
Sex: Female, Male (Count of Participants)
Female	5 31.3%	5 31.3%	10 31.3%
Male	11 68.8%	11 68.8%	22 68.8%
Race/Ethnicity, Customized (participants) [Number]
Caucasian	12 75%	12 75%	24 75%
Hispanic/Latino	0 0%	1 6.3%	1 3.1%
African American	4 25%	3 18.8%	7 21.9%
Region of Enrollment (participants) [Number]
United States	16 100%	16 100%	32 100%
BMI (kilograms per meter squared) [Median (Full Range) ]
Median (Full Range) [kilograms per meter squared]	24.7	25.0	24.7
Number of donor sites (number of sites) [Median (Full Range) ]
Median (Full Range) [number of sites]	2	1.5	2
Baseline donor site size (centimeters squared) [Median (Full Range) ]
Median (Full Range) [centimeters squared]	139.5	136.0	136.0

Outcome Measures

1. Primary Outcome

Title	Rate of Wound Healing
Description	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.
Time Frame	Days to absence of drainage from the initial donor site harvest procedure

Outcome Measure Data

Analysis Population Description

randomized participants that had a minimum of 4 out of 5 treatments

Arm/Group Title	MIST Therapy in Conjunction With Standard Care	Control Arm
Arm/Group Description	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 (Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma) on a daily basis for 5 days.	Standard of care treatment Standard of care: Standard of care provided per site-specific protocol Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma
Measure Participants	13	14
Mean (Standard Deviation) [Days]	12.1 (6.0)	21.3 (14.7)

2. Secondary Outcome

Title	Time to Full Epithelialization
Description	Time to full epithelialization in days from the date of initial donor site harvest procedure per the blinded adjudication of the donor site image.
Time Frame	Days to full epithelialization

Outcome Measure Data

Analysis Population Description

randomized subjects that had a minimum of 4 out of 5 study treatments

Arm/Group Title	MIST Therapy in Conjunction With Standard Care	Control Arm
Arm/Group Description	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 (Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma) on a daily basis for 5 days.	Standard of care treatment Standard of care: Standard of care provided per site-specific protocol Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma
Measure Participants	13	14
Mean (Standard Deviation) [days]	18.2 (8.8)	27.5 (12.2)

3. Secondary Outcome

Title	Numeric Pain Score
Description	Average donor site pain score for each treatment group, numeric scale of 0 (no pain) to 10 (worst possible pain), at five weeks post skin graft procedure
Time Frame	5 weeks

Outcome Measure Data

Analysis Population Description

randomized subjects that had a minimum of 4 out of 5 study treatments and with a numeric pain score reported

Arm/Group Title	MIST Therapy in Conjunction With Standard Care	Control Arm
Arm/Group Description	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 (Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma) on a daily basis for 5 days.	Standard of care treatment Standard of care: Standard of care provided per site-specific protocol Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma
Measure Participants	10	10
Mean (Standard Error) [units on a scale]	0 (.964)	1.8 (.964)

4. Secondary Outcome

Title	Numeric Itching Score
Description	Average donor site itching score for treatment group, numeric scale 0 (no itch) to 10 (worst possible itch), at 5 weeks post skin graft procedure
Time Frame	5 weeks

Outcome Measure Data

Analysis Population Description

Randomized subjects with a minimum of 4 out of 5 study treatments and itching score reported

Arm/Group Title	MIST Therapy in Conjunction With Standard Care	Control Arm
Arm/Group Description	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 (Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma) on a daily basis for 5 days.	Standard of care treatment Standard of care: Standard of care provided per site-specific protocol Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma
Measure Participants	10	9
Mean (Standard Error) [units on a scale]	0.7 (1.3)	4.1 (1.3)

5. Secondary Outcome

Title	Donor Site Recidivism Rate
Description	Number of donor sites that healed and then reopened during the study.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

Randomized subjects that had a minimum of 4 out of 5 study treatments and fully epithelialized during the study.

Arm/Group Title	MIST Therapy in Conjunction With Standard Care	Control Arm
Arm/Group Description	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 (Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma) on a daily basis for 5 days.	Standard of care treatment Standard of care: Standard of care provided per site-specific protocol Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma
Measure Participants	13	11
Number [participants that healed and reopened]	1 6.3%	5 31.3%

Adverse Events

Time Frame	6 weeks post skin graft procedure
Adverse Event Reporting Description	Device related events and infections
Arm/Group Title	MIST Therapy in Conjunction With Standard Care		Control Arm
Arm/Group Description	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 (Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma) on a daily basis for 5 days.		Standard of care treatment Standard of care: Standard of care provided per site-specific protocol Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma
All Cause Mortality
	MIST Therapy in Conjunction With Standard Care		Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	MIST Therapy in Conjunction With Standard Care		Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/16 (0%)
Other (Not Including Serious) Adverse Events
	MIST Therapy in Conjunction With Standard Care		Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/16 (25%)		4/16 (25%)
General disorders
Discomfort	3/16 (18.8%)	3	0/16 (0%)	0
Infections and infestations
Infection	1/16 (6.3%)	1	4/16 (25%)	4

Limitations/Caveats

Participants were not blinded to study treatment.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.