Partial-thickness BurnNCT02519621
NPWT PRO vs KCI Ulta® NPWT and to Compare NPWT PRO vs NPWT PRO With Simultaneous Irrigation on Wound Healing
A study testing NPWT PRO without irrigation, NPWT PRO with irrigation and KCI Ulta in people with Partial-thickness Burn and Ulcer, run by Larry Lavery at 2 sites in United States.
Trial summary
This study is designed to assess the efficacy and economics of two NPWT (negative pressure wound therapy) branded devices of wound healing outcomes. It is also designed to assess the effectiveness of negative pressure and negative pressure with continuous irrigation on multiple parameters of wound healing. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Partial-thickness Burn, Ulcer
- What is being tested?
- NPWT PRO without irrigation, NPWT PRO with irrigation and KCI Ulta
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2016to 24 Jun 2020
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presents with an existing chronic or traumatic wound, sub-acute or dehisced wound, partial-thickness burn, ulcer (such as a diabetic or pressure ulcer), flap or graft as diagnosed by a qualified and certified medical practitioner (M.D., D.O., or D.P.M)
- Wound presents with full thickness loss of epidermis and dermis
- The presentation of a wound that in the opinion of the investigators will require surgical debridement, and the wound is expected to be a good candidate for NPWT and eventual wound closure.
- ABI≥0.5 or toe pressures >30 PVR/mmHg
- Subject is willing and able to abstain from partaking in any other form of treatment for his or her wound throughout the duration of his or her course of participation in the clinical study, other than the study procedures described herein.
- 18 years of age or older
Who cannot join
- Does not present with an existing chronic or traumatic wound, sub-acute or dehisced wound, partial-thickness burn, ulcer (such as a diabetic or pressure ulcer), flap or graft, or a definitive diagnosis cannot be made, as diagnosed by a qualified and certified medical practitioner (M.D., D.O., or D.P.M)
- Wound does not present with full thickness loss of epidermis and dermis
- ABI<0.5 or toe pressures <30 PVR/mmHg
- Subject is not willing or is not able or it is not medically prudent for the subject to abstain from partaking in any other form of treatment for his or her wound throughout the duration of his or her course of participation in the clinical study, other than the study procedures described.
- Subject is unwilling or unable to use the NPWT device at home
- Active Charcot arthropathy
Show all 29Show fewer
- Collagen vascular disease
- Scleroderma
- Non-enteric and unexplored fistula
- Necrotic tissue with eschar present after debridement
- General skin disorder in the area of the wound such as psoriasis or penicilitis
- Malnutrition (defined as BMI <19)
- Hypercoagulable state based on documentation in their medical record
- Acute deep vein thrombosis
- Current active malignancy in the wound
- Current melanoma or history of melanoma at the wound
- Current active or history of invasive squamous cell carcinoma at the wound
- Sepsis (defined as positive blood culture with leukocytosis) and temperature >101.5 at the time of screening
- Significant Hematologic disorders EXCLUDING anemia
- HIV
- Fever at screening > 101.5
- Deep X-ray therapy
- Untreated bone or soft tissue infection (osteomyelitis)
- Any concomitant illness(es) or medical condition(s) that in the opinion of the investigator would render the subject not suited for study participation
- Subject is taking a regimen of any medication(s) in a significant enough dosage that may affect chronic wound healing, including corticosteroid, chemotherapeutic and non-steroidal anti-inflammatory (NSAID) medications
- Less than 18 years of age
- Developmental disability/significant psychological disorder that could impair the subject's ability to provide informed consent, participate in the study protocol or record study measures, including schizophrenia, bipolar disorder and psychiatric hospitalization within the last 2 years.
- Females currently pregnant or planning pregnancy during the course of intended participation in the study
- Active alcohol or substance abuse in the opinion of the investigator that could impair the subjects ability to provide informed consent, participate in the study protocol or record study measures.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UT Southwestern Medical Center
Dallas, Texas, 75390
UT Southwestern
Dallas, Texas, 75390
About this study
Official title: A Pilot Study to Compare the Efficacy of NPWT PRO Versus KCI Ulta® NPWT and to Compare NPWT PRO Versus NPWT PRO With Simultaneous Irrigation on Wound Healing
This study is designed to assess the efficacy and economics of two NPWT (negative pressure wound therapy) branded devices of wound healing outcomes. It is also designed to assess the effectiveness of negative pressure and negative pressure with continuous irrigation on multiple parameters of wound healing. It is a single-center, open-label, active controlled, parallel-group trial that aims to determine the efficacy of Quantum with simultaneous irrigation in the treatment of diabetic foot ulcers. Specifically, eligible participants will be randomized to receive either PRO negative press therapy with simultaneous irrigation; or PRO negative pressure therapy without irrigation; or KCI Ulta negative pressure therapy. Outcomes will include rates of wound healing, time to closure, number of surgeries, length of stay, and days to heal.
Read the detailed description
Subjects will be taken to the operating room for the initial debridement procedure of the wound. At the end of the procedure, subjects who continue to meet all inclusion and no exclusion criteria will be randomized in a 1:1:1 ratio to be treated with either PRO, PRO with simultaneous irrigation (PROI), or KCI Ulta NPWT. Prior to study initiation sealed prenumbered randomization envelopes will be provided to the research staff and used to obtain randomization assignment. Opening of the randomization envelope will occur intraoperatively at the conclusion of the initial surgical debridement of the wound and conformation of all eligibility requirements. Study staff will use the randomization number labels contained in the envelop. The number will become the subject ID. The assignment will be subjects randomized to PRO, PRO with simultaneous irrigation, or KCI Ulta NPWT.
The research staff will note treatment assignments on the intra operative randomization CRF and instruct the investigator. Treatment therapy wound dressings will be applied in the operating room or in the patient's room immediately after surgery per the investigators discretion, according to the manufacturer's recommendations. In order to ensure consistent study treatment, subjects will receive assigned treatment therapies within their study arm after the initial and any subsequent surgical debridements until the wound is deemed ready for closure or coverage by the Investigator. Subjects randomized to the PRO with simultaneous irrigation Treatment arm are the only subjects that will receive irrigation therapy at any time during the study treatment period. If irrigation therapy is discontinued, subjects in the Treatment arm will transition to PRO NPWT without irrigation. Subjects randomized to the PRO Control arm will receive NPWT only from the PRO therapy unit.
- Conditions
- Partial-thickness Burn, Ulcer
- Being tested
- NPWT PRO without irrigation, NPWT PRO with irrigation, KCI Ulta
- Keywords
- diabetic ulcer, pressure ulcer, chronic or traumatic wound, sub-acute or dehisced wound
- Medical subject headings
- Ulcer, Pressure Ulcer, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPWT PRO without irrigationDevice
Also called Cardinal Quantum NPWT PRO
NPWT PRO without irrigation.
NPWT PRO with irrigationDevice
Also called Cardinal Quantum NPWT PRO
NPWT PRO with irrigation (saline)
KCI UltaDevice
KCI Ulta NPWT without irrigation
| Study group | Role | What they receive |
|---|---|---|
| NPWT PRO without irrigation | Active comparator | Cardinal Health NPWT PRO system (K143016) continuous/intermittent vacuum-assisted drainage Receives: Device: NPWT PRO without irrigation |
| NPWT PRO with Irrigation | Active comparator | Cardinal Health NPWT PRO system (K143016) continuous/intermittent vacuum-assisted drainage with simultaneous delivery of topical wound treatment solutions and suspensions over the wound bed (saline irrigant). Receives: Device: NPWT PRO with irrigation |
| KCI Ulta NPWT | Active comparator | KCI Ulta NPWT without irrigation. Receives: Device: KCI Ulta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Achieved Complete Wound Healing
Complete healing of wounds as defined by epithelialization with no drainage in three treatment arms: NPWT PRO versus KCI Ulta® NPWT and to Compare NPWT PRO versus NPWT PRO with Simultaneous Irrigation
Measured: 12 weeks
Secondary outcomes (3)
Number of Surgeries
Number of surgeries required to debride infection before wound was ready for closure or coverage.
Measured: 12 weeks
Length of Stay
Number of days the patient stayed in the hospital
Measured: 12 weeks
Days to Heal
The number of days to heal the wound after last surgery was performed.
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 posted11 Aug 2015 (estimated)
- Study startApr 2016
- Primary completionJan 2019
- Study completion24 Jun 2020
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 Partial-thickness BurnStudies 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Larry Lavery
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Larry Lavery, University of Texas Southwestern Medical Center
- Investigators
- Lawrence A Lavery, DPM, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02519621
- Sponsor's protocol ID
- STU 032015-099
- Status last verified
- Jul 2023
- First submitted
- 1 Jun 2015
- Last updated
- 24 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Compare the Efficacy of NPWT PRO Versus KCI Ulta® NPWT and to Compare NPWT PRO Versus NPWT PRO With Simultaneous Irrigation on Wound Healing
- ClinicalTrials.gov ID
- NCT02519621
- Acronym / sponsor ID
- STU 032015-099
- Conditions
- Partial-thickness Burn, Ulcer
- Keywords
- diabetic ulcer, pressure ulcer, chronic or traumatic wound, sub-acute or dehisced wound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Larry LaveryUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- 24 Jun 2020 (actual)
- First posted
- 11 Aug 2015 (estimated)
- Results
- Posted 14 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to assess the efficacy and economics of two NPWT (negative pressure wound therapy) branded devices of wound healing outcomes. It is also designed to assess the effectiveness of negative pressure and negative pressure with continuous irrigation on multiple parameters of wound healing. It is a single-center, open-label, active controlled, parallel-group trial that aims to determine the efficacy of Quantum with simultaneous irrigation in the treatment of diabetic foot ulcers. Specifically, eligible participants will be randomized to receive either PRO negative press therapy with simultaneous irrigation; or PRO negative pressure therapy without irrigation; or KCI Ulta negative pressure therapy. Outcomes will include rates of wound healing, time to closure, number of surgeries, length of stay, and days to heal.
Detailed description
Subjects will be taken to the operating room for the initial debridement procedure of the wound. At the end of the procedure, subjects who continue to meet all inclusion and no exclusion criteria will be randomized in a 1:1:1 ratio to be treated with either PRO, PRO with simultaneous irrigation (PROI), or KCI Ulta NPWT. Prior to study initiation sealed prenumbered randomization envelopes will be provided to the research staff and used to obtain randomization assignment. Opening of the randomization envelope will occur intraoperatively at the conclusion of the initial surgical debridement of the wound and conformation of all eligibility requirements. Study staff will use the randomization number labels contained in the envelop. The number will become the subject ID. The assignment will be subjects randomized to PRO, PRO with simultaneous irrigation, or KCI Ulta NPWT.
The research staff will note treatment assignments on the intra operative randomization CRF and instruct the investigator. Treatment therapy wound dressings will be applied in the operating room or in the patient's room immediately after surgery per the investigators discretion, according to the manufacturer's recommendations. In order to ensure consistent study treatment, subjects will receive assigned treatment therapies within their study arm after the initial and any subsequent surgical debridements until the wound is deemed ready for closure or coverage by the Investigator. Subjects randomized to the PRO with simultaneous irrigation Treatment arm are the only subjects that will receive irrigation therapy at any time during the study treatment period. If irrigation therapy is discontinued, subjects in the Treatment arm will transition to PRO NPWT without irrigation. Subjects randomized to the PRO Control arm will receive NPWT only from the PRO therapy unit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NPWT PRO without irrigation | Active comparator | Device: NPWT PRO without irrigationCardinal Health NPWT PRO system (K143016) continuous/intermittent vacuum-assisted drainage |
| NPWT PRO with Irrigation | Active comparator | Device: NPWT PRO with irrigationCardinal Health NPWT PRO system (K143016) continuous/intermittent vacuum-assisted drainage with simultaneous delivery of topical wound treatment solutions and suspensions over the wound bed (saline irrigant). |
| KCI Ulta NPWT | Active comparator | Device: KCI UltaKCI Ulta NPWT without irrigation. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Presents with an existing chronic or traumatic wound, sub-acute or dehisced wound, partial-thickness burn, ulcer (such as a diabetic or pressure ulcer), flap or graft as diagnosed by a qualified and certified medical practitioner (M.D., D.O., or D.P.M)
- Wound presents with full thickness loss of epidermis and dermis
- The presentation of a wound that in the opinion of the investigators will require surgical debridement, and the wound is expected to be a good candidate for NPWT and eventual wound closure.
- ABI≥0.5 or toe pressures >30 PVR/mmHg
- Subject is willing and able to abstain from partaking in any other form of treatment for his or her wound throughout the duration of his or her course of participation in the clinical study, other than the study procedures described herein.
Key exclusion criteria (29 listed)
- Does not present with an existing chronic or traumatic wound, sub-acute or dehisced wound, partial-thickness burn, ulcer (such as a diabetic or pressure ulcer), flap or graft, or a definitive diagnosis cannot be made, as diagnosed by a qualified and certified medical practitioner (M.D., D.O., or D.P.M)
- Wound does not present with full thickness loss of epidermis and dermis
- ABI<0.5 or toe pressures <30 PVR/mmHg
- Subject is not willing or is not able or it is not medically prudent for the subject to abstain from partaking in any other form of treatment for his or her wound throughout the duration of his or her course of participation in the clinical study, other than the study procedures described.
- Subject is unwilling or unable to use the NPWT device at home
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 |
|---|---|---|
| NPWT PRO without irrigationAlso: Cardinal Quantum NPWT PRONPWT PRO without irrigation. | Device | NPWT PRO without irrigation |
| NPWT PRO with irrigationAlso: Cardinal Quantum NPWT PRONPWT PRO with irrigation (saline) | Device | NPWT PRO with Irrigation |
| KCI UltaKCI Ulta NPWT without irrigation | Device | KCI Ulta NPWT |
Primary outcome
Number of Participants Who Achieved Complete Wound Healing
Time frame: 12 weeks
Complete healing of wounds as defined by epithelialization with no drainage in three treatment arms: NPWT PRO versus KCI Ulta® NPWT and to Compare NPWT PRO versus NPWT PRO with Simultaneous Irrigation
3 secondary outcomes
Number of Surgeries
Time frame: 12 weeks
Length of Stay
Time frame: 12 weeks
Days to Heal
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- 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.
Lawrence A Lavery, DPM principal investigator
University of Texas Southwestern Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NPWT PRO without irrigation, NPWT PRO with irrigation and KCI Ulta in people with Partial-thickness Burn and Ulcer, run by Larry Lavery at 2 sites 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 6 inclusion and 29 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 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 14 Aug 2020). 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?
Number of Participants Who Achieved Complete Wound Healing (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 24 Jul 2023; AzTrials last refreshed its copy on 6 Nov 2026.