Negative Pressure Wound Therapy for the Treatment of Chronic Pressure Wounds

NCT00691821 | Terminated Phase 4

• 1 other identifier: HTA012-0801-01
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to assess the difference in the percent reduction in wound surface area, without surgery, of chronic pressure ulcers of the pelvic region for Negative Pressure Wound Therapy (NPWT) compared to the standard dressing. This study is designed to provide evidence regarding NPWT as compared to standard dressing regimens and compare the efficacy, safety, effectiveness and cost-effectiveness.

Conditions

Skin Ulcer; Pressure Ulcer

Keywords

Negative-Pressure Wound Therapy; Bandages; Community Health Services

Outcome Measures

Primary Outcomes (1)

• The primary outcome is the percent reduction in wound surface area, without surgery, at 12 weeks compared to wound measurements at treatment initiation following randomization.

  12 Weeks

Secondary Outcomes (1)

• Wound healing, effectiveness, safety, healthcare resource utilization, costing, quality of life, cost effectiveness analysis

  12 Weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Standard Dressings

Other: Standard Dressings

2

EXPERIMENTAL

Negative Pressure Wound Therapy

Device: Negative Pressure Wound Therapy (Vacuum-Assisted Closure System [V.A.C.® Therapy™, KCI Medical Canada Inc., Mississauga, Ontario])

Interventions

Standard Dressings OTHER

Participants will receive standard dressings changes as needed. Different dressing types (e.g., silver, simple gauze, hydrogel, foam, creams, gels) will be used dependent on the type of the wound (e.g., dry, wet, and intermediate).

1

Negative Pressure Wound Therapy (Vacuum-Assisted Closure System [V.A.C.® Therapy™, KCI Medical Canada Inc., Mississauga, Ontario]) DEVICE

Participants will receive negative pressure wound therapy.

Also known as: V.A.C. Therapy

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• All chronic pressure wounds of the pelvic region except trochanteric wounds.
• Chronic pressure wound defined as the presence of a pressure wound for \> 6 weeks and \< 6 months with no sign of improvement in healing
• Wound size surface area \> 2cm2
• Stage III-IV pressure ulcer according to the National Pressure Ulcer Advisory Panel (NPUAP)
• No clinical signs of active infection at the wound site and currently not on antibiotics
• Willingness to off-load or pressure redistribute ulcer

You may not qualify if:

• Candidate for surgery in the next 12 weeks
• A wound with necrotic tissue unable to tolerate debridement
• Exposed blood vessels and/or organs within the wound
• Chronic osteomyelitis (as determined by biopsy) or osteomyelitis that is not treatable by debridement and antibiotics
• Non-enteric or unexplored fistulae
• Wounds requiring hemostasis (i.e., that the flow of blood be stopped) for local bleeding
• Alternate etiology for non-healing
• Concomitant conditions that in the judgment of the investigator would make the subject inappropriate for entry to the study (e.g., malignancy in wound, malignancy less than 1-year disease free interval, previous or current irradiation, known immunodeficiency and/or major uncorrected medical disorders such as serious non-malignant disease, serious cardiovascular or pulmonary disease, lupus, inflammatory bowel disease, palliative care or sickle cell disease)
• Poor nutritional status as determined by a Braden Scale Nutritional Assessment score of 2 or 1 with a serum albumin \< 25 g/L and hemoglobin \< 90 g/L
• Currently taking medication that may interfere with wound healing (e.g., oral systemic steroids, immunosuppressive drugs, unfractionated heparin infusion)
• Women who are currently pregnant or are breast feeding; or women of child bearing potential who are not currently taking adequate birth control
• Participation in another investigative drug or device trial currently or within the last 30 days

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead
• Ontario Ministry of Health and Long Term Care: collaborator
• Unity Health Toronto: collaborator
• Women's College Hospital: collaborator
• Hamilton Niagara Haldimand Brant Community Care Access Centre: collaborator
• Toronto Central Community Care Access Centre: collaborator

Study Sites (4)

Niagara Branch - Hamilton Niagara Haldimand Brant Community Care Access Centre

Saint Catherines, Ontario, L2P 1N6, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location

Toronto Central Community Care Access Centre

Toronto, Ontario, M5T 2Z5, Canada

Location

MeSH Terms

Conditions

Skin Ulcer; Pressure Ulcer

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Study Officials

• Ron Goeree, MA

  Programs for Assessment of Technology in Health Research Institute

  STUDY CHAIR

• James Mahoney, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

• Gary Sibbald, MD

  Women's College

  PRINCIPAL INVESTIGATOR

• Maureen Kitson

  Niagara Region Community Care Access Centre

  PRINCIPAL INVESTIGATOR

• Joanne Greco, BScN

  Toronto Central Community Care Access Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 27, 2008
• First Posted: June 5, 2008
• Study Start: April 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: July 26, 2011

Record last verified: 2011-07

Locations

CA (4)