Partial-thickness Burn, Ulcer
Conditions
Keywords
diabetic ulcer, pressure ulcer, chronic or traumatic wound, sub-acute or dehisced wound
Brief 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. 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.
Interventions
DEVICENPWT PRO without irrigation
NPWT PRO without irrigation.
DEVICENPWT PRO with irrigation
NPWT PRO with irrigation (saline)
DEVICEKCI Ulta
KCI Ulta NPWT without irrigation
Sponsors
Larry Lavery
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Achieved Complete Wound Healing | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Surgeries | 12 weeks | Number of surgeries required to debride infection before wound was ready for closure or coverage. |
| Length of Stay | 12 weeks | Number of days the patient stayed in the hospital |
| Days to Heal | 12 weeks | The number of days to heal the wound after last surgery was performed. |
Countries
United States
Participant flow
Pre-assignment details
93 were consented but 3 of them did not have the vac/treatment, so therefore 90 total (30 in each group).
Participants by arm
| Arm | Count |
|---|---|
| NPWT PRO Without Irrigation Cardinal Health NPWT PRO system (K143016) continuous/intermittent vacuum-assisted drainage
NPWT PRO without irrigation: NPWT PRO without irrigation. | 30 |
| NPWT PRO With Irrigation 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).
NPWT PRO with irrigation: NPWT PRO with irrigation (saline) | 30 |
| KCI Ulta NPWT KCI Ulta NPWT without irrigation.
KCI Ulta: KCI Ulta NPWT without irrigation | 30 |
| Total | 90 |
Baseline characteristics
| Characteristic | NPWT PRO Without Irrigation | NPWT PRO With Irrigation | KCI Ulta NPWT | Total |
|---|---|---|---|---|
| Age, Continuous | 49.50 years STANDARD_DEVIATION 9.95 | 53.80 years STANDARD_DEVIATION 12.21 | 51.70 years STANDARD_DEVIATION 9.44 | 51.67 years STANDARD_DEVIATION 10.63 |
| Race/Ethnicity, Customized African American | 4 Participants | 9 Participants | 1 Participants | 14 Participants |
| Race/Ethnicity, Customized Caucasian | 10 Participants | 1 Participants | 5 Participants | 16 Participants |
| Race/Ethnicity, Customized Hispanic | 16 Participants | 20 Participants | 24 Participants | 60 Participants |
| Region of Enrollment United States | 30 participants | 30 participants | 30 participants | 90 participants |
| Sex: Female, Male Female | 5 Participants | 7 Participants | 4 Participants | 16 Participants |
| Sex: Female, Male Male | 25 Participants | 23 Participants | 26 Participants | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 4 / 30 | 5 / 30 | 5 / 30 |
| serious Total, serious adverse events | 4 / 30 | 4 / 30 | 4 / 30 |
Outcome results
Primary
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
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NPWT PRO Without Irrigation | Number of Participants Who Achieved Complete Wound Healing | 15 Participants |
| NPWT PRO With Irrigation | Number of Participants Who Achieved Complete Wound Healing | 19 Participants |
| KCI Ulta NPWT | Number of Participants Who Achieved Complete Wound Healing | 14 Participants |
Secondary
Days to Heal
The number of days to heal the wound after last surgery was performed.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NPWT PRO Without Irrigation | Days to Heal | 41.0 days | Standard Deviation 6.3 |
| NPWT PRO With Irrigation | Days to Heal | 43.0 days | Standard Deviation 9.4 |
| KCI Ulta NPWT | Days to Heal | 42.0 days | Standard Deviation 13.1 |
Secondary
Length of Stay
Number of days the patient stayed in the hospital
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NPWT PRO Without Irrigation | Length of Stay | 14.7 days | Standard Deviation 7.4 |
| NPWT PRO With Irrigation | Length of Stay | 16.3 days | Standard Deviation 15.7 |
| KCI Ulta NPWT | Length of Stay | 15.3 days | Standard Deviation 10.5 |
Secondary
Number of Surgeries
Number of surgeries required to debride infection before wound was ready for closure or coverage.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NPWT PRO Without Irrigation | Number of Surgeries | 2.4 surgeries | Standard Deviation 0.77 |
| NPWT PRO With Irrigation | Number of Surgeries | 2.0 surgeries | Standard Deviation 0.49 |
| KCI Ulta NPWT | Number of Surgeries | 2.4 surgeries | Standard Deviation 0.68 |