Negative Pressure Wound Therapy: Are All Systems Alike?

Wounds Clinical Trial

Official title:

Negative Pressure Wound Therapy: Are All Systems Alike?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00590369
• Other study ID #: 8309-c
• Secondary ID: OSR 20050803
• Status: Terminated
• Phase: Phase 3
• First received: December 26, 2007
• Last updated: March 30, 2012
• Start date: January 2006
• Est. completion date: August 2008

Study information

• Verified date: March 2012
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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).

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.

Other known NCT identifiers

• NCT00583141

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Wounds

Intervention

Device:
• KCI -VAC
Negative pressure wound therapy device
• Versatile One (EZCare)
Negative pressure wound therapy device

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	Smith & Nephew, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5 Measures of Wound Healing: Length, Width, Depth, Undermining, Tunneling	differences in wound healing rate at first dressing between devices; since 5 variables were assessed via a centimeter ruler	first dressing change; typically within 48 hours	No
Secondary	Ease of Performing Dressing Change	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	during hospital stay; generally 6 days	No
Secondary	Ease of Providing Nursing Care	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	during hospital stay; generally 6 days	No
Secondary	Cost of Wound Care	cost of device/supplies used in application and dressing changes	during hospital stay; generally 6 days	No
Secondary	Nursing Time		hospital stay; generally 6 days	No
Secondary	Patient Reported Pain	scale of 0= no pain to 10= worst pain possible	at first dressing change; generally 48 hours	No