Status:
TERMINATED
Negative Pressure Wound Therapy for the Treatment of Chronic Pressure Wounds
Lead Sponsor:
St. Joseph's Healthcare Hamilton
Collaborating Sponsors:
Ontario Ministry of Health and Long Term Care
Unity Health Toronto
Conditions:
Skin Ulcer
Pressure Ulcer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 Thera...
Detailed Description
The Ontario Health Technology Advisory Committee recommended that a study should be completed due to the large numbers of patients needing chronic wound care and the increasing use of NPWT based on po...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2010
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT00691821
Start Date
April 1 2009
End Date
May 1 2010
Last Update
July 26 2011
Active Locations (4)
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1
Niagara Branch - Hamilton Niagara Haldimand Brant Community Care Access Centre
Saint Catherines, Ontario, Canada, L2P 1N6
2
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
3
Women's College Hospital
Toronto, Ontario, Canada, M5S 1B2
4
Toronto Central Community Care Access Centre
Toronto, Ontario, Canada, M5T 2Z5