Clinical trial NCT04593693: A Dual-center Study Evaluating Clinical Acceptance of a NPWT Wound Care System
Official title: A Dual-center Study 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
Surgical Wound
Acute Wound
Traumatic Wound
Dehiscence
Edema
Keywords: Negative Pressure Wound Therapy
Invia Motion
Lead sponsor: Medela AG
Sponsor class: INDUSTRY
Collaborators: name: Joseph M. Still Research Foundation, Inc.
First posted: 2020-10-20
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to 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 is to evaluate whether clinical opinion of product performance results in expected wound response and outcomes 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
* Decrease in edema/periwound swelling
* 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\*\*

Eligibility criteria: Inclusion Criteria:

* Adult subjects ≥18 years of age.
* Signed, informed consent by patient or LAR
* Patient is determined to be in need of NPWT for treatment of a diabetic foot ulcer, pressure injuries, and pressure ulcer, surgical wounds, acute/traumatic wounds and dehisced wounds, abscesses, or to prepare the wound bed for grafting or closure and/or to decrease edema
* 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 follow up (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: Goal of therapy: Change in wound volume
timeFrame: Up to 4 week study duration
measure: Goal of therapy: Change in size of the tunneling area
timeFrame: Up to 4 week study duration
measure: Goal of therapy: Change in size of undermining
timeFrame: Up to 4 week study duration
measure: Goal of therapy: Change in amount of slough
timeFrame: Up to 4 week study duration
measure: Goal of therapy: Change in granulation tissue
timeFrame: Up to 4 week study duration
measure: Goal of therapy: Change in edema/periwound swelling
timeFrame: Up to 4 week study duration
measure: Goal of therapy: 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
timeFrame: Up to 4 week study duration
Secondary outcomes:
measure: Evaluate the ease of use from clinicians
timeFrame: Up to 4 week study duration
measure: Evaluate overall satisfaction from clinicians
timeFrame: Up to 4 week study duration
Other outcomes:
measure: Determine performance satisfaction of dressing components on periwound
timeFrame: Up to 4 week study duration
Locations:
city: Augusta
country: United States
facility: Joseph M. Still Burn Center and Wound Clinic at Doctors Hospital
state: Georgia
city: Austell
country: United States
facility: JMS Burn Centers, Inc. at Wellstar Cobb Hospital
state: Georgia
Study officials:
affiliation: Joseph M. Still Research Foundation, Inc.
name: Claus Brandigi, MD
role: PRINCIPAL_INVESTIGATOR
References: