Trial Outcomes & Findings for Split Thickness Donor Site Healing With MIST Study (NCT NCT01214980)

NCT ID: NCT01214980

Last Updated: 2014-12-19

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 32 participants
• Primary outcome timeframe: Days to absence of drainage from the initial donor site harvest procedure
• Results posted on: 2014-12-19

Participant Flow

Participant milestones

Measure	MIST Therapy in Conjunction With Standard Care 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.	Control Arm 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
Overall Study STARTED	16	16
Overall Study COMPLETED	13	14
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Split Thickness Donor Site Healing With MIST Study

Baseline characteristics by cohort

Measure	MIST Therapy in Conjunction With Standard Care n=16 Participants 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.	Control Arm n=16 Participants 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 n=32 Participants Total of all reporting groups
Age, Continuous	32 years n=5 Participants	54 years n=7 Participants	49 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	12 participants n=5 Participants	12 participants n=7 Participants	24 participants n=5 Participants
Race/Ethnicity, Customized Hispanic/Latino	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized African American	4 participants n=5 Participants	3 participants n=7 Participants	7 participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants	16 participants n=7 Participants	32 participants n=5 Participants
BMI	24.7 kilograms per meter squared n=5 Participants	25.0 kilograms per meter squared n=7 Participants	24.7 kilograms per meter squared n=5 Participants
Number of donor sites	2 number of sites n=5 Participants	1.5 number of sites n=7 Participants	2 number of sites n=5 Participants
Baseline donor site size	139.5 centimeters squared n=5 Participants	136.0 centimeters squared n=7 Participants	136.0 centimeters squared n=5 Participants

PRIMARY outcome

Timeframe: Days to absence of drainage from the initial donor site harvest procedure

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

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.

Outcome measures

Measure	MIST Therapy in Conjunction With Standard Care n=13 Participants 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.	Control Arm n=14 Participants 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
Rate of Wound Healing	12.1 Days Standard Deviation 6.0	21.3 Days Standard Deviation 14.7

SECONDARY outcome

Timeframe: Days to full epithelialization

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

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

Outcome measures

Measure	MIST Therapy in Conjunction With Standard Care n=13 Participants 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.	Control Arm n=14 Participants 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
Time to Full Epithelialization	18.2 days Standard Deviation 8.8	27.5 days Standard Deviation 12.2

SECONDARY outcome

Timeframe: 5 weeks

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

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

Outcome measures

Measure	MIST Therapy in Conjunction With Standard Care n=10 Participants 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.	Control Arm n=10 Participants 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
Numeric Pain Score	0 units on a scale Standard Error .964	1.8 units on a scale Standard Error .964

SECONDARY outcome

Timeframe: 5 weeks

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

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

Outcome measures

Measure	MIST Therapy in Conjunction With Standard Care n=10 Participants 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.	Control Arm n=9 Participants 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
Numeric Itching Score	0.7 units on a scale Standard Error 1.3	4.1 units on a scale Standard Error 1.3

SECONDARY outcome

Timeframe: 6 weeks

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

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

Outcome measures

Measure	MIST Therapy in Conjunction With Standard Care n=13 Participants 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.	Control Arm n=11 Participants 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
Donor Site Recidivism Rate	1 participants that healed and reopened	5 participants that healed and reopened

Adverse Events

MIST Therapy in Conjunction With Standard Care

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Control Arm

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	MIST Therapy in Conjunction With Standard Care n=16 participants at risk 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.	Control Arm n=16 participants at risk 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
Infections and infestations Infection	6.2% 1/16 • Number of events 1 • 6 weeks post skin graft procedure Device related events and infections	25.0% 4/16 • Number of events 4 • 6 weeks post skin graft procedure Device related events and infections
General disorders Discomfort	18.8% 3/16 • Number of events 3 • 6 weeks post skin graft procedure Device related events and infections	0.00% 0/16 • 6 weeks post skin graft procedure Device related events and infections

Additional Information

Dr. Lisa Gould

University South Florida

Phone: (410) 736-4646

Email: lgould44@hotmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place