NPWT PRO vs KCI Ulta® NPWT and to Compare NPWT PRO vs NPWT PRO With Simultaneous Irrigation on Wound Healing

• Sponsor: Larry Lavery (Other)
• Overall Status: Completed
• CT.gov ID: NCT02519621
• Collaborator: (none)
• Enrollment: 90
• Locations: 2
• Arms: 3
• Actual Duration (Months): 50.8
• Patients Per Site: 45
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Partial-thickness Burn; Ulcer	Device: NPWT PRO without irrigation; Device: NPWT PRO with irrigation; Device: KCI Ulta	N/A

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

• Study Type: Interventional
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Apr 1, 2016
• Actual Primary Completion Date: Jan 1, 2019
• Actual Study Completion Date: Jun 24, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: NPWT PRO without irrigation Cardinal Health NPWT PRO system (K143016) continuous/intermittent vacuum-assisted drainage	Device: NPWT PRO without irrigation; NPWT PRO without irrigation.; Other Names: Cardinal Quantum NPWT PRO
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).	Device: NPWT PRO with irrigation; NPWT PRO with irrigation (saline); Other Names: Cardinal Quantum NPWT PRO
Active Comparator: KCI Ulta NPWT KCI Ulta NPWT without irrigation.	Device: KCI Ulta; KCI Ulta NPWT without irrigation

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Number of Surgeries [12 weeks]

   Number of surgeries required to debride infection before wound was ready for closure or coverage.

2. Length of Stay [12 weeks]

   Number of days the patient stayed in the hospital

3. Days to Heal [12 weeks]

   The number of days to heal the wound after last surgery was performed.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 89 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UT Southwestern Medical Center	Dallas	Texas	United States	75390
2	UT Southwestern	Dallas	Texas	United States	75390

Sponsors and Collaborators

• Larry Lavery

Investigators

• Principal Investigator: Lawrence A Lavery, DPM, UT Southwestern Medical Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 5, 2020

More Information

Publications

None provided.

• Responsible Party: Larry Lavery, Professor and Director of Research, University of Texas Southwestern Medical Center
• ClinicalTrials.gov Identifier: NCT02519621
• Other Study ID Numbers: STU 032015-099
• First Posted: Aug 11, 2015
• Last Update Posted: Aug 14, 2020
• Last Verified: Aug 1, 2020

• Keywords provided by Larry Lavery, Professor and Director of Research, University of Texas Southwestern Medical Center: diabetic ulcer; pressure ulcer; chronic or traumatic wound; sub-acute or dehisced wound
• Additional relevant MeSH terms: Ulcer

Study Results

Participant Flow

Pre-assignment Detail	93 were consented but 3 of them did not have the vac/treatment, so therefore 90 total (30 in each group).

Arm/Group Title	NPWT PRO Without Irrigation	NPWT PRO With Irrigation	KCI Ulta NPWT
Arm/Group Description	Cardinal Health NPWT PRO system (K143016) continuous/intermittent vacuum-assisted drainage NPWT PRO without irrigation: NPWT PRO without 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)	KCI Ulta NPWT without irrigation. KCI Ulta: KCI Ulta NPWT without irrigation
Period Title: Overall Study
STARTED	30	30	30
COMPLETED	30	30	30
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	NPWT PRO Without Irrigation	NPWT PRO With Irrigation	KCI Ulta NPWT	Total
Arm/Group Description	Cardinal Health NPWT PRO system (K143016) continuous/intermittent vacuum-assisted drainage NPWT PRO without irrigation: NPWT PRO without 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)	KCI Ulta NPWT without irrigation. KCI Ulta: KCI Ulta NPWT without irrigation	Total of all reporting groups
Overall Participants	30	30	30	90
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.50 (9.95)	53.80 (12.21)	51.70 (9.44)	51.67 (10.63)
Sex: Female, Male (Count of Participants)
Female	5 16.7%	7 23.3%	4 13.3%	16 17.8%
Male	25 83.3%	23 76.7%	26 86.7%	74 82.2%
Race/Ethnicity, Customized (Count of Participants)
Caucasian	10 33.3%	1 3.3%	5 16.7%	16 17.8%
African American	4 13.3%	9 30%	1 3.3%	14 15.6%
Hispanic	16 53.3%	20 66.7%	24 80%	60 66.7%
Region of Enrollment (participants) [Number]
United States	30 100%	30 100%	30 100%	90 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Who Achieved Complete Wound Healing
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NPWT PRO Without Irrigation	NPWT PRO With Irrigation	KCI Ulta NPWT
Arm/Group Description	Cardinal Health NPWT PRO system (K143016) continuous/intermittent vacuum-assisted drainage NPWT PRO without irrigation: NPWT PRO without 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)	KCI Ulta NPWT without irrigation. KCI Ulta: KCI Ulta NPWT without irrigation
Measure Participants	30	30	30
Count of Participants [Participants]	15 50%	19 63.3%	14 46.7%

2. Secondary Outcome

Title	Number of Surgeries
Description	Number of surgeries required to debride infection before wound was ready for closure or coverage.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NPWT PRO Without Irrigation	NPWT PRO With Irrigation	KCI Ulta NPWT
Arm/Group Description	Cardinal Health NPWT PRO system (K143016) continuous/intermittent vacuum-assisted drainage NPWT PRO without irrigation: NPWT PRO without 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)	KCI Ulta NPWT without irrigation. KCI Ulta: KCI Ulta NPWT without irrigation
Measure Participants	30	30	30
Mean (Standard Deviation) [surgeries]	2.4 (0.77)	2.0 (0.49)	2.4 (0.68)

3. Secondary Outcome

Title	Length of Stay
Description	Number of days the patient stayed in the hospital
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NPWT PRO Without Irrigation	NPWT PRO With Irrigation	KCI Ulta NPWT
Arm/Group Description	Cardinal Health NPWT PRO system (K143016) continuous/intermittent vacuum-assisted drainage NPWT PRO without irrigation: NPWT PRO without 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)	KCI Ulta NPWT without irrigation. KCI Ulta: KCI Ulta NPWT without irrigation
Measure Participants	30	30	30
Mean (Standard Deviation) [days]	14.7 (7.4)	16.3 (15.7)	15.3 (10.5)

4. Secondary Outcome

Title	Days to Heal
Description	The number of days to heal the wound after last surgery was performed.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NPWT PRO Without Irrigation	NPWT PRO With Irrigation	KCI Ulta NPWT
Arm/Group Description	Cardinal Health NPWT PRO system (K143016) continuous/intermittent vacuum-assisted drainage NPWT PRO without irrigation: NPWT PRO without 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)	KCI Ulta NPWT without irrigation. KCI Ulta: KCI Ulta NPWT without irrigation
Measure Participants	30	30	30
Mean (Standard Deviation) [days]	41.0 (6.3)	43.0 (9.4)	42.0 (13.1)

Adverse Events

Time Frame	Adverse events during 12 weeks
Arm/Group Title	NPWT PRO Without Irrigation		NPWT PRO With Irrigation		KCI Ulta NPWT
Arm/Group Description	Cardinal Health NPWT PRO system (K143016) continuous/intermittent vacuum-assisted drainage NPWT PRO without irrigation: NPWT PRO without 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)		KCI Ulta NPWT without irrigation. KCI Ulta: KCI Ulta NPWT without irrigation
All Cause Mortality
	NPWT PRO Without Irrigation		NPWT PRO With Irrigation		KCI Ulta NPWT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)		0/30 (0%)
Serious Adverse Events
	NPWT PRO Without Irrigation		NPWT PRO With Irrigation		KCI Ulta NPWT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/30 (13.3%)		4/30 (13.3%)		4/30 (13.3%)
Infections and infestations
Foot related readmission	4/30 (13.3%)	4	4/30 (13.3%)	4	4/30 (13.3%)	4
Other (Not Including Serious) Adverse Events
	NPWT PRO Without Irrigation		NPWT PRO With Irrigation		KCI Ulta NPWT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/30 (13.3%)		5/30 (16.7%)		5/30 (16.7%)
Infections and infestations
Reinfection of study foot	4/30 (13.3%)	4	5/30 (16.7%)	5	5/30 (16.7%)	5

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.