Trial Outcomes & Findings for Negative Pressure Wound Therapy: Are All Systems Alike? (NCT NCT00590369)

Results Overview

differences in wound healing rate at first dressing between devices; since 5 variables were assessed via a centimeter ruler

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

11 participants

Primary outcome timeframe

first dressing change; typically within 48 hours

Results posted on

2012-04-02

Participant Flow

Jan 2006-March 2008; study recruitment; study stopped due to slow enrollment rate

Participant milestones

Participant milestones
Measure	KCI VAC KCI VAC type negative pressure wound therapy device	Versatile One Versatile One (EZCare)negative wound therapy device
Overall Study STARTED	6	5
Overall Study COMPLETED	6	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Negative Pressure Wound Therapy: Are All Systems Alike?

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	KCI VAC n=6 Participants KCI VAC type negative pressure wound therapy device	Versatile One n=5 Participants Versatile One (EZCare)negative wound therapy device	Total n=11 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age Continuous median	57 years INTER_QUARTILE_RANGE 42, 58 • n=5 Participants	49 years INTER_QUARTILE_RANGE 47, 50 • n=7 Participants	50 years INTER_QUARTILE_RANGE 42, 58 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	5 participants n=7 Participants	11 participants n=5 Participants

PRIMARY outcome

Timeframe: first dressing change; typically within 48 hours

differences in wound healing rate at first dressing between devices; since 5 variables were assessed via a centimeter ruler

Outcome measures

Outcome measures
Measure	KCI VAC n=6 Participants KCI VAC type negative pressure wound therapy device	Versatile One n=5 Participants Versatile One (EZCare)negative wound therapy device
5 Measures of Wound Healing: Length, Width, Depth, Undermining, Tunneling Depth of wound	2.5 centimeters Interval 1.6 to 3.7	2.2 centimeters Interval 2.0 to 3.0
5 Measures of Wound Healing: Length, Width, Depth, Undermining, Tunneling Length of wound	10.6 centimeters Interval 6.5 to 13.8	16.5 centimeters Interval 4.8 to 21.0
5 Measures of Wound Healing: Length, Width, Depth, Undermining, Tunneling Width of wound	2.75 centimeters Interval 1.5 to 5.0	4.2 centimeters Interval 3.5 to 5.5
5 Measures of Wound Healing: Length, Width, Depth, Undermining, Tunneling Undermining of wound	0 centimeters Interval 0.0 to 0.5	0 centimeters Interval 0.0 to 0.0
5 Measures of Wound Healing: Length, Width, Depth, Undermining, Tunneling Tunneling of wound	0 centimeters Interval 0.0 to 0.0	0 centimeters Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: during hospital stay; generally 6 days

responses to questions using a Likert scale regarding ease of dressing change; 8 characteristics; only reported is: Apply/fasten occlusive drape to secure drainage tube; scale range is 0, very difficult to do, takes a lot of time or effort or not possible to 10, simple or very easy to do

Outcome measures

Outcome measures
Measure	KCI VAC n=6 Participants KCI VAC type negative pressure wound therapy device	Versatile One n=5 Participants Versatile One (EZCare)negative wound therapy device
Ease of Performing Dressing Change	8.5 scores on a scale Interval 7.0 to 10.0	6.0 scores on a scale Interval 5.0 to 8.0

SECONDARY outcome

Timeframe: during hospital stay; generally 6 days

nurse perception of ease of providing nursing care using a Likert-type scale; 5 items assessed. Responses to 1 item provided: Overall experience with nursing care issues related to the wound device. score range is 0, always very difficult, always a problem or not possible to 10, always easy, never or rarely a problem

Outcome measures

Outcome measures
Measure	KCI VAC n=6 Participants KCI VAC type negative pressure wound therapy device	Versatile One n=5 Participants Versatile One (EZCare)negative wound therapy device
Ease of Providing Nursing Care	10 scores on a scale Interval 9.0 to 10.0	8.0 scores on a scale Interval 6.0 to 10.0

SECONDARY outcome

Timeframe: during hospital stay; generally 6 days

cost of device/supplies used in application and dressing changes

Outcome measures

Outcome measures
Measure	KCI VAC n=6 Participants KCI VAC type negative pressure wound therapy device	Versatile One n=5 Participants Versatile One (EZCare)negative wound therapy device
Cost of Wound Care	510.18 dollars (USD) Standard Deviation 419.77	333.54 dollars (USD) Standard Deviation 71.69

SECONDARY outcome

Timeframe: hospital stay; generally 6 days

Outcome measures

Outcome measures
Measure	KCI VAC n=6 Participants KCI VAC type negative pressure wound therapy device	Versatile One n=5 Participants Versatile One (EZCare)negative wound therapy device
Nursing Time	33.2 minutes Standard Deviation 23.8	38.8 minutes Standard Deviation 19.9

SECONDARY outcome

Timeframe: at first dressing change; generally 48 hours

scale of 0= no pain to 10= worst pain possible

Outcome measures

Outcome measures
Measure	KCI VAC n=6 Participants KCI VAC type negative pressure wound therapy device	Versatile One n=5 Participants Versatile One (EZCare)negative wound therapy device
Patient Reported Pain	3.2 units on a scale Standard Deviation 3.7	2.4 units on a scale Standard Deviation 2.3

Adverse Events

KCI VAC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Versatile One

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nancy M. Albert PhD, RN

Cleveland Clinic

Phone: 216-444-7028

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place