N/A
N=90
NPWT PRO vs KCI Ulta® NPWT and to Compare NPWT PRO vs NPWT PRO With Simultaneous Irrigation on Wound Healing
Partial-thickness Burn · Ulcer
Bottom Line
View on ClinicalTrials.gov: NCT02519621 ↗Enrolled (actual)
90
Serious AEs
13.3%
Results posted
Aug 2020
Primary outcome: Primary: Number of Participants Who Achieved Complete Wound Healing — 15; 19; 14 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- NPWT PRO without irrigation (Device); NPWT PRO with irrigation (Device); KCI Ulta (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Larry Lavery
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Achieved Complete Wound Healing |
15; 19; 14 | — |
| SECONDARY Number of Surgeries |
2.4; 2.0; 2.4 | — |
| SECONDARY Length of Stay |
14.7; 16.3; 15.3 | — |
| SECONDARY Days to Heal |
41.0; 43.0; 42.0 | — |
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.
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT02519621). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.