Skin UlcerPhase 4NPWTNCT00691821
Negative Pressure Wound Therapy for the Treatment of Chronic Pressure Wounds
A Phase 4 study testing Standard Dressings and Negative Pressure Wound Therapy (Vacuum-Assisted Closure System [V.A.C.® Therapy™, KCI Medical Canada Inc., Mississauga, Ontario]) in people with Skin Ulcer and Pressure Ulcer, run by St. Joseph's Healthcare Hamilton at 4 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Ulcer, Pressure Ulcer
- What is being tested?
- Standard Dressings and Negative Pressure Wound Therapy (Vacuum-Assisted Closure System [V.A.C.® Therapy™, KCI Medical Canada Inc., Mississauga, Ontario])
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 4 sitesCanada
- Study dates
- Apr 2009to May 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Niagara Branch - Hamilton Niagara Haldimand Brant Community Care Access Centre
Saint Catherines, Ontario, L2P 1N6
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Women's College Hospital
Toronto, Ontario, M5S 1B2
Toronto Central Community Care Access Centre
Toronto, Ontario, M5T 2Z5
About this study
Official title: A 12-week, Prospective, Open-label, Randomized, Controlled Clinical Trial Comparing Negative Pressure Wound Therapy (NPWT) to Standard Wound Care for the Treatment of Chronic Pressure Wounds of the Pelvic Region
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.
Read the 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 poor quality evidence to identify any potential indications for the use of NPWT. This study is designed to provide evidence regarding NPWT as compared to standard dressing regimens in Ontario and the results will serve as a benchmark for the utilization of NPWT in chronic pressure wounds, establishing and providing guidance regarding the use of NPWT in this population of subjects and to support policy decision making regarding the funding of the NPWT in the province. Specifically, this will compare the efficacy, effectiveness and cost-effectiveness of NPWT with standard dressing regimens for the treatment of chronic pressure ulcers of the pelvic region.
This is a prospective, randomized, open-label, controlled clinical trial comparing standardized wound dressing (control arm) to NPWT (experimental arm) for the treatment of chronic pressure wounds of the pelvic region. NPWT will be performed using the Vacuum-Assisted Closure System (V.A.C.® Therapy™, KCI Medical Canada Inc., Mississauga, Ontario). NPWT will be compared to the present recommended state of the art wound dressings in subjects who would be candidates for either type of wound therapy. Both arms will receive standard wound care (e.g., debridement, preventative care, infection control, etc.). The efficacy, effectiveness, safety, and quality of life will be evaluated for standardized wound dressing versus NPWT. Complications associated with either form of wound care will be documented. An economic evaluation will be conducted in order to assess the cost-effectiveness and cost-utility of NPWT compared to standard wound dressing. It is anticipated that 184 subjects will be enrolled and randomized over a 1.5 year period. All subjects providing consent and meeting inclusion/exclusion criteria will be randomized to either treatment arm and followed for 12 weeks. Patients who have wound closure within the 12-week study period will continue to have wound care visits as scheduled. All subjects will have Wound Evaluation Visits and Wound Dressing Change Visits. Wound Evaluation Visits will occur at baseline, 2, 4, 6, 8 and 12 weeks after the date of randomization, where following removal of the dressing, a detailed wound assessment (e.g., wound characteristics, measurements) will be done and healthcare resource utilization will be collected. Disease specific quality of life measures and preference based quality of life measures (EQ-5D) will be collected at baseline, 6 weeks and at 12 weeks. Dressing Change Visits will occur as clinically required and the frequency of dressing changes per week will be allowed to vary over the 12 weeks of the study. During the dressing change visits, subjects will be monitored for wound infection and other complications. Subjects may be enrolled and randomized in the clinic and transferred to the community with continued follow-up completed by the appropriate Community Care Access Centre.
- Conditions
- Skin Ulcer, Pressure Ulcer
- Being tested
- Standard Dressings, Negative Pressure Wound Therapy (Vacuum-Assisted Closure System [V.A.C.® Therapy™, KCI Medical Canada Inc., Mississauga, Ontario])
- Keywords
- Negative-Pressure Wound Therapy, Bandages, Community Health Services
- Medical subject headings
- Skin Ulcer, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard DressingsOther
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).
Negative Pressure Wound Therapy (Vacuum-Assisted Closure System [V.A.C.® Therapy™, KCI Medical Canada Inc., Mississauga, Ontario])Device
Also called V.A.C. Therapy
Participants will receive negative pressure wound therapy.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Standard Dressings Receives: Other: Standard Dressings |
| 2 | Experimental | Negative Pressure Wound Therapy Receives: Device: Negative Pressure Wound Therapy (Vacuum-Assisted Closure System [V.A.C.® Therapy™, KCI Medical Canada Inc., Mississauga, Ontario]) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 Weeks
Secondary outcomes (1)
Wound healing, effectiveness, safety, healthcare resource utilization, costing, quality of life, cost effectiveness analysis
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2008 (estimated)
- Study startApr 2009
- Primary completionMay 2010
- Study completionMay 2010
Why it stopped: Patients not meeting inclusion criteria, therefore recruitment rate low, terminated due to the lack of feasibility to complete the study in a timely manner.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care, Unity Health Toronto, Women's College Hospital, Hamilton Niagara Haldimand Brant Community Care Access Centre, Toronto Central Community Care Access Centre
- Investigators
- Ron Goeree, MA, Study chair, Programs for Assessment of Technology in Health Research InstituteJames Mahoney, MD, Principal investigator, Unity Health TorontoGary Sibbald, MD, Principal investigator, Women's CollegeMaureen Kitson, Principal investigator, Niagara Region Community Care Access CentreJoanne Greco, BScN, Principal investigator, Toronto Central Community Care Access Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00691821
- Sponsor's protocol ID
- HTA012-0801-01
- Acronym
- NPWT
- Status last verified
- Jul 2011
- First submitted
- 27 May 2008
- Last updated
- 26 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week, Prospective, Open-label, Randomized, Controlled Clinical Trial Comparing Negative Pressure Wound Therapy (NPWT) to Standard Wound Care for the Treatment of Chronic Pressure Wounds of the Pelvic Region
- ClinicalTrials.gov ID
- NCT00691821
- Acronym / sponsor ID
- NPWT / HTA012-0801-01
- Conditions
- Skin Ulcer, Pressure Ulcer
- Keywords
- Negative-Pressure Wound Therapy, Bandages, Community Health Services
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Patients not meeting inclusion criteria, therefore recruitment rate low, terminated due to the lack of feasibility to complete the study in a timely manner.
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care, Unity Health Toronto, Women's College Hospital, Hamilton Niagara Haldimand Brant Community Care Access Centre, Toronto Central Community Care Access Centre
- Study start
- Apr 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 5 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 poor quality evidence to identify any potential indications for the use of NPWT. This study is designed to provide evidence regarding NPWT as compared to standard dressing regimens in Ontario and the results will serve as a benchmark for the utilization of NPWT in chronic pressure wounds, establishing and providing guidance regarding the use of NPWT in this population of subjects and to support policy decision making regarding the funding of the NPWT in the province. Specifically, this will compare the efficacy, effectiveness and cost-effectiveness of NPWT with standard dressing regimens for the treatment of chronic pressure ulcers of the pelvic region.
This is a prospective, randomized, open-label, controlled clinical trial comparing standardized wound dressing (control arm) to NPWT (experimental arm) for the treatment of chronic pressure wounds of the pelvic region. NPWT will be performed using the Vacuum-Assisted Closure System (V.A.C.® Therapy™, KCI Medical Canada Inc., Mississauga, Ontario). NPWT will be compared to the present recommended state of the art wound dressings in subjects who would be candidates for either type of wound therapy. Both arms will receive standard wound care (e.g., debridement, preventative care, infection control, etc.). The efficacy, effectiveness, safety, and quality of life will be evaluated for standardized wound dressing versus NPWT. Complications associated with either form of wound care will be documented. An economic evaluation will be conducted in order to assess the cost-effectiveness and cost-utility of NPWT compared to standard wound dressing. It is anticipated that 184 subjects will be enrolled and randomized over a 1.5 year period. All subjects providing consent and meeting inclusion/exclusion criteria will be randomized to either treatment arm and followed for 12 weeks. Patients who have wound closure within the 12-week study period will continue to have wound care visits as scheduled. All subjects will have Wound Evaluation Visits and Wound Dressing Change Visits. Wound Evaluation Visits will occur at baseline, 2, 4, 6, 8 and 12 weeks after the date of randomization, where following removal of the dressing, a detailed wound assessment (e.g., wound characteristics, measurements) will be done and healthcare resource utilization will be collected. Disease specific quality of life measures and preference based quality of life measures (EQ-5D) will be collected at baseline, 6 weeks and at 12 weeks. Dressing Change Visits will occur as clinically required and the frequency of dressing changes per week will be allowed to vary over the 12 weeks of the study. During the dressing change visits, subjects will be monitored for wound infection and other complications. Subjects may be enrolled and randomized in the clinic and transferred to the community with continued follow-up completed by the appropriate Community Care Access Centre.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Standard DressingsStandard Dressings |
| 2 | Experimental | Device: Negative Pressure Wound Therapy (Vacuum-Assisted Closure System [V.A.C.® Therapy™, KCI Medical Canada Inc., Mississauga, Ontario])Negative Pressure Wound Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard DressingsParticipants 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). | Other | 1 |
| Negative Pressure Wound Therapy (Vacuum-Assisted Closure System [V.A.C.® Therapy™, KCI Medical Canada Inc., Mississauga, Ontario])Also: V.A.C. TherapyParticipants will receive negative pressure wound therapy. | Device | 2 |
Primary outcome
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.
Time frame: 12 Weeks
1 secondary outcome
Wound healing, effectiveness, safety, healthcare resource utilization, costing, quality of life, cost effectiveness analysis
Time frame: 12 Weeks
Results and safety
The study was stopped early (reason given: Patients not meeting inclusion criteria, therefore recruitment rate low, terminated due to the lack of feasibility to complete the study in a timely manner.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ron Goeree, MA study chair
Programs for Assessment of Technology in Health Research Institute
James Mahoney, MD principal investigator
Unity Health Toronto
Gary Sibbald, MD principal investigator
Women's College
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Standard Dressings and Negative Pressure Wound Therapy (Vacuum-Assisted Closure System [V.A.C.® Therapy™, KCI Medical Canada Inc., Mississauga, Ontario]) in people with Skin Ulcer and Pressure Ulcer, run by St. Joseph's Healthcare Hamilton at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Patients not meeting inclusion criteria, therefore recruitment rate low, terminated due to the lack of feasibility to complete the study in a timely manner.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2011.