Clinical trial NCT03670225: Evaluating Clinical Acceptance of a NPWT Wound Care System
Official title: Evaluating Clinical Acceptance of a NPWT Wound Care System to Expected Standards of Care in Post-acute Patients With a Variety of Wound Types
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Ulcer
Pressure Injury
Pressure Ulcer
Lead sponsor: Medela AG
Sponsor class: INDUSTRY
Collaborators: name: Joseph M. Still Research Foundation, Inc.
First posted: 2018-09-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: non-randomized
Primary purpose: TREATMENT

Brief summary: Determine if use of the Medela Invia Motion NPWT system supports acceptable progress towards the goal of therapy when treating patients with a variety of wound types during the evaluation period.

Detailed description: The primary objective of this study is to determine acceptable progress towards the goal of therapy for a diabetic foot ulcers (DFU) and pressure Injuries/ulcers (PI/PU) wounds when using the Medela Invia Motion Endure NPWT system during 4-week study duration.

Goal of therapy will be defined by the physician according to initial assessment:

Endpoints (dependent on goal of therapy):

* Decrease in wound volume
* Decrease in size of the tunneling area
* Decrease in size of undermining
* Decrease in amount of slough
* Increase in granulation tissue
* The wound bed is progressing acceptably towards a transition to another treatment modality such as Moist Wound Healing (MWH), surgical closure, or a flap or graft.

\*\*Study endpoint will be determined by physician at the time of enrollment, when the goal of therapy is documented\*\*

B. Secondary Objectives

* To evaluate the ease of use from clinicians.
* To evaluate overall satisfaction from clinicians. C. Tertiary Objectives
* Adequate management of the exudate

Eligibility criteria: Inclusion Criteria:

* Adult subjects ≥18 years of age.
* Signed, informed consent by patient or LAR within 72 hours of admission to burn center.
* Patient is determined to be in need of NPWT for treatment of a diabetic foot ulcer, pressure injuries/pressure ulcer.
* Patient is comfortable (e.g. not in pain)
* Patient is willing and able to adhere to treatment protocol.

Exclusion Criteria:

* Patient not willing to comply with f/u clinic visits.
* Subjects with

  * Necrotic tissue with eschar present
  * Untreated osteomyelitis
  * Non-enteric and unexplored fistulas
  * Malignancy in wound
  * Exposed vasculature
  * Exposed nerves
  * Exposed anastomotic site of blood vessels or bypasses
  * Exposed organs
* Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
* Patients with concurrent conditions or co-morbidities that in the opinion of the investigator may compromise patient safety or study objectives.

Primary outcomes:
measure: Determine if Invia Motion Endure supports acceptable progress towards the goal of therapy for DFU and PI/PU wounds
timeFrame: 4 weeks
Secondary outcomes:
measure: Evaluation of ease of use and satisfaction
timeFrame: 4 weeks
Other outcomes:
measure: Adequate management of the exudate
timeFrame: 4 weeks
Locations:
city: Augusta
country: United States
facility: Joseph M. Still Research Foundation
state: Georgia
Study officials:
affiliation: Joseph M. Still Research Foundation
name: Robert F Mullins, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sen CK, Gordillo GM, Roy S, Kirsner R, Lambert L, Hunt TK, Gottrup F, Gurtner GC, Longaker MT. Human skin wounds: a major and snowballing threat to public health and the economy. Wound Repair Regen. 2009 Nov-Dec;17(6):763-71. doi: 10.1111/j.1524-475X.2009.00543.x.
citation: Morrison Informatics, Inc. A comprehensive cost analysis of medicare home oxygen therapy: A study for the American Association for Homecare. June 27, 2006.
citation: C. Marquardt et. al. "Negative pressure wound therapy using PHMB gauze for the management of postoperative subcutaneous surgical site infections" Coloproctology" 36:364-369, 2014