- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02519621
NPWT PRO vs KCI Ulta® NPWT and to Compare NPWT PRO vs NPWT PRO With Simultaneous Irrigation on Wound Healing
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75390
- UT Southwestern Medical Center
-
Dallas, Texas, United States, 75390
- UT Southwestern
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: NPWT PRO without irrigation
Cardinal Health NPWT PRO system (K143016) continuous/intermittent vacuum-assisted drainage
|
NPWT PRO without irrigation.
Other Names:
|
Active Comparator: 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 (saline)
Other Names:
|
Active Comparator: KCI Ulta NPWT
KCI Ulta NPWT without irrigation.
|
KCI Ulta NPWT without irrigation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Surgeries
Time Frame: 12 weeks
|
Number of surgeries required to debride infection before wound was ready for closure or coverage.
|
12 weeks
|
Length of Stay
Time Frame: 12 weeks
|
Number of days the patient stayed in the hospital
|
12 weeks
|
Days to Heal
Time Frame: 12 weeks
|
The number of days to heal the wound after last surgery was performed.
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lawrence A Lavery, DPM, UT Southwestern Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU 032015-099
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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