Trial Outcomes & Findings for Negative Pressure Wound Therapy as a Drug Delivery System (NCT NCT02463487)
NCT ID: NCT02463487
Last Updated: 2023-07-24
Results Overview
How many wounds fully healed in 16 weeks. Healing defined as fully epithelialized skin with no drainage.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
150 participants
Primary outcome timeframe
16 weeks
Results posted on
2023-07-24
Participant Flow
The study population was comprised of patients who were admitted to hospital with a moderate or severe foot infection that required incision and drainage and parenteral antibiotics and for whom negative pressure wound therapy (NPWT) was indicated. Patients who fit the criteria for the study were then recruited.
The patients underwent a screening exam including * evaluating sensory neuropathy with loss of protective sensation with a 10-gram monofilament * Vibration Perception Threshold Testing * ABI - ankle brachial index * SPP - skin perfusion pressure * Peripheral arterial disease (PAD) was defined as either ABI \<0.9 or SPP \<30 mm Hg.
Participant milestones
| Measure |
Cardinal Pro + Irrigation (NPWTi)
Negative Pressure Wound Therapy with Irrigation: Quantum™ +Simultaneous Irrigation (NPWTi) - Negative Pressure Wound Therapy with Prontosan® Intervention is receiving the Cardinal Vac with Irrigation
Cardinal Pro +Simultaneous Irrigation (NPWTi): NPWT with low volume irrigation (15 cc/hr) with 1% polyhexanide biguanide (PHMB), Prontosan®
|
Cardinal Pro (NPWT) Therapy
Negative Pressure Wound Therapy without Irrigation: Quantum™ (NPWT) -Negative Pressure Wound Therapy (without Prontosan®) Intervention is receiving the Cardinal Vac without Irrigation
Cardinal Pro (NPWT) Therapy: NPWT 125 mm Hg continuous pressure with foam interface
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
75
|
|
Overall Study
COMPLETED
|
65
|
65
|
|
Overall Study
NOT COMPLETED
|
10
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Negative Pressure Wound Therapy as a Drug Delivery System
Baseline characteristics by cohort
| Measure |
Cardinal Pro (NPWT) Therapy
n=75 Participants
Negative Pressure Wound Therapy without Irrigation: Quantum™ (NPWT) -Negative Pressure Wound Therapy (without Prontosan®) Intervention is receiving the Cardinal Vac without Irrigation
Cardinal Pro (NPWT) Therapy: NPWT 125 mm Hg continuous pressure with foam interface
|
Cardinal Pro + Irrigation (NPWTi)
n=75 Participants
Negative Pressure Wound Therapy with Irrigation: Quantum™ +Simultaneous Irrigation (NPWTi) - Negative Pressure Wound Therapy with Prontosan® Intervention is receiving the Cardinal Vac with Irrigation
Cardinal Pro +Simultaneous Irrigation (NPWTi): NPWT with low volume irrigation (15 cc/hr) with 1% polyhexanide biguanide (PHMB), Prontosan®
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.32 years
STANDARD_DEVIATION 8.22 • n=5 Participants
|
49.07 years
STANDARD_DEVIATION 9.74 • n=7 Participants
|
50.19 years
STANDARD_DEVIATION 9.05 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
21 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
23 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 16 weeksHow many wounds fully healed in 16 weeks. Healing defined as fully epithelialized skin with no drainage.
Outcome measures
| Measure |
Cardinal Pro (NPWT) Therapy
n=75 Participants
Negative Pressure Wound Therapy without Irrigation: Quantum™ (NPWT) -Negative Pressure Wound Therapy (without Prontosan®) Intervention is receiving the Cardinal Vac without Irrigation
Cardinal Pro (NPWT) Therapy: NPWT 125 mm Hg continuous pressure with foam interface
|
Cardinal Pro + Irrigation (NPWTi)
n=75 Participants
Negative Pressure Wound Therapy with Irrigation: Quantum™ +Simultaneous Irrigation (NPWTi) - Negative Pressure Wound Therapy with Prontosan® Intervention is receiving the Cardinal Vac with Irrigation
Cardinal Pro +Simultaneous Irrigation (NPWTi): NPWT with low volume irrigation (15 cc/hr) with 1% polyhexanide biguanide (PHMB), Prontosan®
|
|---|---|---|
|
Number of Participants Who Achieved Complete Healing or Coverage of the Study Wound
|
44 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: 16 WeeksTotal number of adverse events, including new foot ulcer formation, all-cause hospital readmission, and foot-related hospital readmission.
Outcome measures
| Measure |
Cardinal Pro (NPWT) Therapy
n=75 Participants
Negative Pressure Wound Therapy without Irrigation: Quantum™ (NPWT) -Negative Pressure Wound Therapy (without Prontosan®) Intervention is receiving the Cardinal Vac without Irrigation
Cardinal Pro (NPWT) Therapy: NPWT 125 mm Hg continuous pressure with foam interface
|
Cardinal Pro + Irrigation (NPWTi)
n=75 Participants
Negative Pressure Wound Therapy with Irrigation: Quantum™ +Simultaneous Irrigation (NPWTi) - Negative Pressure Wound Therapy with Prontosan® Intervention is receiving the Cardinal Vac with Irrigation
Cardinal Pro +Simultaneous Irrigation (NPWTi): NPWT with low volume irrigation (15 cc/hr) with 1% polyhexanide biguanide (PHMB), Prontosan®
|
|---|---|---|
|
Total Adverse Events of Participants
Foot-related readmission
|
13 Participants
|
14 Participants
|
|
Total Adverse Events of Participants
New ulcer formation
|
12 Participants
|
18 Participants
|
|
Total Adverse Events of Participants
All-cause readmission
|
26 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: 16 weeksDehiscence is defined as any part of a surgically closed wound that failed to heal when sutures were removed.
Outcome measures
| Measure |
Cardinal Pro (NPWT) Therapy
n=75 Participants
Negative Pressure Wound Therapy without Irrigation: Quantum™ (NPWT) -Negative Pressure Wound Therapy (without Prontosan®) Intervention is receiving the Cardinal Vac without Irrigation
Cardinal Pro (NPWT) Therapy: NPWT 125 mm Hg continuous pressure with foam interface
|
Cardinal Pro + Irrigation (NPWTi)
n=75 Participants
Negative Pressure Wound Therapy with Irrigation: Quantum™ +Simultaneous Irrigation (NPWTi) - Negative Pressure Wound Therapy with Prontosan® Intervention is receiving the Cardinal Vac with Irrigation
Cardinal Pro +Simultaneous Irrigation (NPWTi): NPWT with low volume irrigation (15 cc/hr) with 1% polyhexanide biguanide (PHMB), Prontosan®
|
|---|---|---|
|
Number of Participants With Wound Dehiscence After Hospital Discharge
|
46 Participants
|
40 Participants
|
Adverse Events
Cardinal Pro (NPWT) Therapy
Serious events: 39 serious events
Other events: 27 other events
Deaths: 0 deaths
Cardinal Pro + Irrigation (NPWTi)
Serious events: 41 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cardinal Pro (NPWT) Therapy
n=75 participants at risk
Negative Pressure Wound Therapy without Irrigation: Quantum™ (NPWT) -Negative Pressure Wound Therapy (without Prontosan®) Intervention is receiving the Cardinal Vac without Irrigation
Cardinal Pro (NPWT) Therapy: NPWT 125 mm Hg continuous pressure with foam interface
|
Cardinal Pro + Irrigation (NPWTi)
n=75 participants at risk
Negative Pressure Wound Therapy with Irrigation: Quantum™ +Simultaneous Irrigation (NPWTi) - Negative Pressure Wound Therapy with Prontosan® Intervention is receiving the Cardinal Vac with Irrigation
Cardinal Pro +Simultaneous Irrigation (NPWTi): NPWT with low volume irrigation (15 cc/hr) with 1% polyhexanide biguanide (PHMB), Prontosan®
|
|---|---|---|
|
Surgical and medical procedures
All-cause hospital readmission
|
34.7%
26/75 • 16 weeks
|
36.0%
27/75 • 16 weeks
|
|
Infections and infestations
Foot-related hospital readmission
|
17.3%
13/75 • 16 weeks
|
18.7%
14/75 • 16 weeks
|
Other adverse events
| Measure |
Cardinal Pro (NPWT) Therapy
n=75 participants at risk
Negative Pressure Wound Therapy without Irrigation: Quantum™ (NPWT) -Negative Pressure Wound Therapy (without Prontosan®) Intervention is receiving the Cardinal Vac without Irrigation
Cardinal Pro (NPWT) Therapy: NPWT 125 mm Hg continuous pressure with foam interface
|
Cardinal Pro + Irrigation (NPWTi)
n=75 participants at risk
Negative Pressure Wound Therapy with Irrigation: Quantum™ +Simultaneous Irrigation (NPWTi) - Negative Pressure Wound Therapy with Prontosan® Intervention is receiving the Cardinal Vac with Irrigation
Cardinal Pro +Simultaneous Irrigation (NPWTi): NPWT with low volume irrigation (15 cc/hr) with 1% polyhexanide biguanide (PHMB), Prontosan®
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
New ulcer formation
|
16.0%
12/75 • 16 weeks
|
24.0%
18/75 • 16 weeks
|
|
Infections and infestations
Reinfection
|
20.0%
15/75 • 16 weeks
|
22.7%
17/75 • 16 weeks
|
Additional Information
Lawrence Lavery, DPM, MPH
UT Southwestern Medical Center at Dallas
Phone: 214-645-0544
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place