Coronary Artery DiseasePhase 1NCT01698372
Negative Pressure Dressing After Saphenous Vein Harvest
A Phase 1 study testing Prevena device (Group A) in people with Coronary Artery Disease and Complication of Coronary Artery Bypass Graft, run by University of Calgary at 1 site in Canada.
Trial summary
This study will test the effectiveness of negative pressure wound therapy (using the VAC Prevena device, KCI Canada Inc.) applied to the saphenous vein harvest site after Coronary Artery Bypass Grafting (CABG). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Complication of Coronary Artery Bypass Graft, Wound Complication
- What is being tested?
- Prevena device (Group A)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2012to Mar 2015
- Phase
- Phase 1
- 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
- Patients presenting for elective or semi-elective isolated first-time CABG surgery with harvesting of the greater saphenous vein.
- Must be 18 years or older.
- Must live with one hour driving distance from Calgary.
- Must provide written consent.
Who cannot join
- Previous CABG surgery or previous lower leg surgical intervention.
- In emergent need for surgery.
- Have severe peripheral vascular disease.
- Do not speak and read the English language.
- Have dialysis-dependent renal failure.
- Require chronic steroids.
- Unable to return to clinic for follow-up due to functional or cognitive impairment.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Libin Cardiovascular Institute, Foothills Medical Centre
Calgary, Alberta, T2N 2T9
About this study
Official title: Negative Pressure Dressing to Decrease the Incidence of Leg Wound Complications After CABG
This study will test the effectiveness of negative pressure wound therapy (using the VAC Prevena device, KCI Canada Inc.) applied to the saphenous vein harvest site after Coronary Artery Bypass Grafting (CABG). When initiated immediately after surgery, this intervention may decrease the incidence of wound infection and non-infectious wound complications. It may decrease wound discomfort and improve mobility and functional recovery of the leg.
- Being tested
- Prevena device (Group A)
- Keywords
- Cardiac surgery., Wound healing., Leg wound infection., Wound care.
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevena device (Group A)Device
Also called Prevena Incision Management System, Prevena 125, PRE1001.S Prevena Incision Kit
This portable device is applied to initiate negative pressure therapy to a wound site.
| Study group | Role | What they receive |
|---|---|---|
| Prevena device (Group A) | Experimental | Group A will have the VAC Prevena portable device applied to the saphenous vein harvest site after standard wound closure following coronary artery bypass surgery. Receives: Device: Prevena device (Group A) |
| Conventional dressing (Group B) | No intervention | Group B will have conventional dry dressing applied to the saphenous vein harvest site after standard wound closure following coronary artery bypass surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline ASEPSIS score of wound healing at 6 weeks.
The ASEPSIS quantitative wound scoring method will be used to assess patients' leg wound healing after saphenous vein harvesting for coronary artery bypass surgery.
Measured: Baseline and 6 weeks
Secondary outcomes (1)
Total score of pain level.
Patients will be asked to evaluate the level of pain (using the Leg Incision Assessment Form) at the wound site after saphenous vein harvesting.
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionNov 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- KCI USA, Inc
- Responsible party
- Principal investigator, Dr. Paul Fedak, University of Calgary
- Investigators
- Paul Fedak, MD, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01698372
- Sponsor's protocol ID
- KCI VAC Study
- Status last verified
- Nov 2015
- First submitted
- 18 Sep 2012
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee AJ, Sheppard CE, Kent WD, Mewhort H, Sikdar KC, Fedak PW. Safety and efficacy of prophylactic negative pressure wound therapy following open saphenous vein harvest in cardiac surgery: a feasibility study. Interact Cardiovasc Thorac Surg. 2017 Mar 1;24(3):324-328. doi: 10.1093/icvts/ivw400.
PubMed 28025309
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Negative Pressure Dressing to Decrease the Incidence of Leg Wound Complications After CABG
- ClinicalTrials.gov ID
- NCT01698372
- Acronym / sponsor ID
- KCI VAC Study
- Keywords
- Cardiac surgery., Wound healing., Leg wound infection., Wound care.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- KCI USA, Inc
- Study start
- Sep 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 3 Oct 2012 (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.
This study will test the effectiveness of negative pressure wound therapy (using the VAC Prevena device, KCI Canada Inc.) applied to the saphenous vein harvest site after Coronary Artery Bypass Grafting (CABG). When initiated immediately after surgery, this intervention may decrease the incidence of wound infection and non-infectious wound complications. It may decrease wound discomfort and improve mobility and functional recovery of the leg.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prevena device (Group A) | Experimental | Device: Prevena device (Group A)Group A will have the VAC Prevena portable device applied to the saphenous vein harvest site after standard wound closure following coronary artery bypass surgery. |
| Conventional dressing (Group B) | No intervention | –Group B will have conventional dry dressing applied to the saphenous vein harvest site after standard wound closure following coronary artery bypass surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients presenting for elective or semi-elective isolated first-time CABG surgery with harvesting of the greater saphenous vein.
- Must be 18 years or older.
- Must live with one hour driving distance from Calgary.
- Must provide written consent.
Key exclusion criteria (7 listed)
- Previous CABG surgery or previous lower leg surgical intervention.
- In emergent need for surgery.
- Have severe peripheral vascular disease.
- Do not speak and read the English language.
- Have dialysis-dependent renal failure.
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 |
|---|---|---|
| Prevena device (Group A)Also: Prevena Incision Management System, Prevena 125, PRE1001.S Prevena Incision KitThis portable device is applied to initiate negative pressure therapy to a wound site. | Device | Prevena device (Group A) |
Primary outcome
Change from baseline ASEPSIS score of wound healing at 6 weeks.
Time frame: Baseline and 6 weeks
The ASEPSIS quantitative wound scoring method will be used to assess patients' leg wound healing after saphenous vein harvesting for coronary artery bypass surgery.
1 secondary outcome
Total score of pain level.
Time frame: Baseline and 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
- Derived from this study: PubMed 28025309Lee AJ, Sheppard CE, Kent WD, Mewhort H, Sikdar KC, Fedak PW. Safety and efficacy of prophylactic negative pressure wound therapy following open saphenous vein harvest in cardiac surgery: a feasibility study. Interact Cardiovasc Thorac Surg. 2017 Mar 1;24(3):324-328. doi: 10.1093/icvts/ivw400.
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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.
Paul Fedak, MD, PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Prevena device (Group A) in people with Coronary Artery Disease and Complication of Coronary Artery Bypass Graft, run by University of Calgary at 1 site 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline ASEPSIS score of wound healing at 6 weeks. (time frame: Baseline and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01698372, which also lists 1 linked publication.
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 2 Dec 2015.