Lower Extremity Wound InfectedNCT02009501
V.A.C. VeraFlo™ Instillation Therapy vs V.A.C. Ulta™ Therapy on Biofilm in Chronically Infected Wounds
A study testing VAC VeraFlo with Dakins Instillation and VAC Ulta Therapy in people with Lower Extremity Wound Infected and Venous Stasis Ulcers, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
Trial summary
This study would like to determine if using negative pressure wound therapy with an instillation of .125% Dakins is more effective than using negative pressure wound therapy alone on biofilm removal, disruption and elimination in chronically infected lower extremity wounds. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Extremity Wound Infected, Venous Stasis Ulcers
- What is being tested?
- VAC VeraFlo with Dakins Instillation and VAC Ulta Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Jun 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- The patient is of 18 years or older.
- Males and females - provided they are not pregnant and if of reproductive age are using contraception.
- Patient with ulcers that:
- Have an ulcer area of at least 4 cm2 confirmed via counting squares on an wound tracing
- Have been present for at least 4 weeks
- Are confirmed to have a colony forming unit per gram of wound tissue greater than or equal to 10 to the 5th cfu
Show all 11Show fewer
- Are full thicknesses through to dermal or subcutaneous tissue but not extending to muscle or bone.
- The patient has an ABI of greater or equal to 0.8 and lower than 1.3 or has a suitable Peripheral Vascular Resistance (PVR) and Doppler assessment which confirms venous disease \& therefore treatment with Profore is deemed acceptable by the clinician.
- The patient has one or more clinical signs of infection (edema, malodor, local/periwound erythema, spontaneous pain between dressing changes, increased exudate, discoloration of granulation tissue, increased temperature at wound, non progression of wound, purulent exudate and friable granulation tissue)
- The patient is able to understand the evaluation and is willing to consent to the evaluation.
- Patients with a suitable wound on a different limb to any other wounds previously eligible.
Who cannot join
- Patients undergoing chemotherapy
- Patients being treated with immunosuppressive drugs or corticosteroids
- Patients with an autoimmune disease
- Patients who have participated in an experimental drug or device study within the last 15 days
- Patients that have been entered in this evaluation previously as an evaluable patient.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Luke's-Roosevelt Hospital Center
New York, New York, 10025
About this study
Official title: A Prospective, Open, Comparative, Randomized Single-center Study to Evaluate the Effect of V.A.C. VeraFlo™ Therapy With .125% Dakins vs V.A.C. Ulta™ Therapy on Biofilm Removal/Disruption/Elimination in Chronically Infected Wounds
This study would like to determine if using negative pressure wound therapy with an instillation of .125% Dakins is more effective than using negative pressure wound therapy alone on biofilm removal, disruption and elimination in chronically infected lower extremity wounds.
- Being tested
- VAC VeraFlo with Dakins Instillation, VAC Ulta Therapy
- Keywords
- Infected wounds, NPWTi, VAC Instill, Biofilm
- Medical subject headings
- Varicose Ulcer, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAC VeraFlo with Dakins InstillationDevice
Also called NPWTi, VAC Instill
VAC VeraFlo with Dakins instillation will be placed in the operating room after surgical debridement. Biopsies will be obtained prior to surgical debridement, after surgical debridement, on day 4, and on day 7.
VAC Ulta TherapyDevice
Also called VAC, NPWT
VAC ULTA will be placed in the operating room after surgical debridement. Biopsies will be obtained prior to surgical debridement, after surgical debridement, on day 4, and on day 7.
| Study group | Role | What they receive |
|---|---|---|
| VAC VeraFlo with Dakins Instillation | Active comparator | VAC VeraFlo with Dakins .125% instillation will be initially applied in the OR after surgical debridement. Dressing will be changed on day 4 and and removed on day 7. Wound assessments will continue at weeks 2, 3, and 4. Receives: Device: VAC VeraFlo with Dakins Instillation |
| VAC Ulta Therapy | Active comparator | VAC ULTA Therapy will be initially applied in the OR after surgical debridement. Dressing will be changed on day 4 and and removed on day 7. Wound assessments will continue at weeks 2, 3, and 4. Receives: Device: VAC Ulta Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bacteria Colony-forming Units Using When NPWT and NPWTi on Venous Leg Ulcers
Biopsies for bacteria colony-forming units obtained at pre surgical debridement (baseline) and day 7.
Measured: Baseline and day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionMay 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lower Extremity Wound InfectedStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's-Roosevelt Hospital Center
- Sponsor type
- University, hospital or other
- Collaborators
- Kinetic Concepts, Inc.
- Responsible party
- Sponsor
- Investigators
- John C Lantis, MD, Principal investigator, St. Luke's-Roosevelt Hospital Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02009501
- Sponsor's protocol ID
- VAC/09/05/ULTA
- Status last verified
- Nov 2018
- First submitted
- 24 Nov 2013
- Last updated
- 27 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open, Comparative, Randomized Single-center Study to Evaluate the Effect of V.A.C. VeraFlo™ Therapy With .125% Dakins vs V.A.C. Ulta™ Therapy on Biofilm Removal/Disruption/Elimination in Chronically Infected Wounds
- ClinicalTrials.gov ID
- NCT02009501
- Acronym / sponsor ID
- VAC/09/05/ULTA
- Keywords
- Infected wounds, NPWTi, VAC Instill, Biofilm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- St. Luke's-Roosevelt Hospital CenterUniversity, hospital or other
- Collaborators
- Kinetic Concepts, Inc.
- Study start
- Nov 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 12 Dec 2013 (estimated)
- Results
- Posted 27 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study would like to determine if using negative pressure wound therapy with an instillation of .125% Dakins is more effective than using negative pressure wound therapy alone on biofilm removal, disruption and elimination in chronically infected lower extremity wounds.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VAC VeraFlo with Dakins Instillation | Active comparator | Device: VAC VeraFlo with Dakins InstillationVAC VeraFlo with Dakins .125% instillation will be initially applied in the OR after surgical debridement. Dressing will be changed on day 4 and and removed on day 7. Wound assessments will continue at weeks 2, 3, and 4. |
| VAC Ulta Therapy | Active comparator | Device: VAC Ulta TherapyVAC ULTA Therapy will be initially applied in the OR after surgical debridement. Dressing will be changed on day 4 and and removed on day 7. Wound assessments will continue at weeks 2, 3, and 4. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- The patient is of 18 years or older.
- Males and females - provided they are not pregnant and if of reproductive age are using contraception.
- Patient with ulcers that:
Key exclusion criteria (5 listed)
- Patients undergoing chemotherapy
- Patients being treated with immunosuppressive drugs or corticosteroids
- Patients with an autoimmune disease
- Patients who have participated in an experimental drug or device study within the last 15 days
- Patients that have been entered in this evaluation previously as an evaluable patient.
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 |
|---|---|---|
| VAC VeraFlo with Dakins InstillationAlso: NPWTi, VAC InstillVAC VeraFlo with Dakins instillation will be placed in the operating room after surgical debridement. Biopsies will be obtained prior to surgical debridement, after surgical debridement, on day 4, and on day 7. | Device | VAC VeraFlo with Dakins Instillation |
| VAC Ulta TherapyAlso: VAC, NPWTVAC ULTA will be placed in the operating room after surgical debridement. Biopsies will be obtained prior to surgical debridement, after surgical debridement, on day 4, and on day 7. | Device | VAC Ulta Therapy |
Primary outcome
Change in Bacteria Colony-forming Units Using When NPWT and NPWTi on Venous Leg Ulcers
Time frame: Baseline and day 7
Biopsies for bacteria colony-forming units obtained at pre surgical debridement (baseline) and day 7.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
John C Lantis, MD principal investigator
St. Luke's-Roosevelt Hospital Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VAC VeraFlo with Dakins Instillation and VAC Ulta Therapy in people with Lower Extremity Wound Infected and Venous Stasis Ulcers, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
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 11 inclusion and 5 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 27 Nov 2018. 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 in Bacteria Colony-forming Units Using When NPWT and NPWTi on Venous Leg Ulcers (time frame: Baseline and day 7). 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 27 Nov 2018; AzTrials last refreshed its copy on 31 Oct 2026.