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Negative Pressure Wound Therapy: Are All Systems Alike?

NeuroTherapia, Inc. logo

NeuroTherapia, Inc.

Status and phase

Terminated
Phase 3

Conditions

Wounds

Treatments

Device: Versatile One (EZCare)
Device: KCI -VAC

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00590369
8309-c
OSR 20050803

Details and patient eligibility

About

Hypotheses: (1)Wound healing during hospital stay will be equal between systems, (2)RNs will perceive the Versatile One (EZCare) system as easier to use, (3)Costs related to dressing changes will be less with Versatile one (EZCare), (4)Hospital length of stay will be equal or shorter with the Versatile One (EzCare) system, (5) Nursing time using Versatile One (EZCare) will be less than or equal to VAC system, (6) Patients will report less pain during dressing changes with Versatile One (EZCare).

Full description

This is a prospective, 2 group, randomized, comparative study (sample:50; 25 in each group) that will investigate whether differences can be found in selected outcomes related to wound care, using Versatile One (EZCare)versus KCI VAC negative pressure/vacuum systems. Only wounds which currently meet criteria for such device use,and for which a physician's order has been written for the device, will be included in this study.

Enrollment

11 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Hospitalized adults requiring negative pressure dressings.

Exclusion criteria

  • Comatose
  • Mentally obtunded
  • Documented chronic psychiatric illness or any documented dementia significant enough to notably impair cognitive function
  • Presence of Manufacturer's contraindications
  • Malignancy in wound
  • Untreated osteomyelitis
  • Unexplored fistula
  • Necrotic tissue
  • Exposed blood vessels or organs
  • Untreated malnutrition.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

11 participants in 2 patient groups

1
Active Comparator group
Description:
KCI VAC type negative pressure wound therapy device
Treatment:
Device: KCI -VAC
2
Experimental group
Description:
Versatile One (EZCare) negative wound therapy device
Treatment:
Device: Versatile One (EZCare)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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