Evaluating Clinical Acceptance of a NPWT Wound Care System

Evaluating Clinical Acceptance of a NPWT Wound Care System to Expected Standards of Care in Post-acute Patients With a Variety of Wound Types

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Ulcer; Pressure Ulcer; Pressure Injury
• Intervention / Treatment: Device: Invia Motion Endure

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

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Joseph M. Still Research Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Invia Motion Endure	Device: Invia Motion Endure; NPWT Invia Motion Endure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine if Invia Motion Endure supports acceptable progress towards the goal of therapy for DFU and PI/PU wounds	Goal of the therapy will be defined by the physician according to initial assessment: 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 enrolment, when the goal of therapy is documented**	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of ease of use and satisfaction	A weekly survey will be obtained from the wound clinic staff members to determine ease of use and satisfaction	4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adequate management of the exudate	Measurament of exudate (ml, number of canisters used) will be performed	4 weeks

Collaborators and Investigators

• Sponsor: Medela AG
• Collaborators: Joseph M. Still Research Foundation, Inc.
• Investigators: Principal Investigator: Robert F Mullins, MD, Joseph M. Still Research Foundation

Publications and helpful links

General Publications

• 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.
• Morrison Informatics, Inc. A comprehensive cost analysis of medicare home oxygen therapy: A study for the American Association for Homecare. June 27, 2006.
• 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

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2018
• Primary Completion (Actual): January 30, 2020
• Study Completion (Actual): January 30, 2020

Study Registration Dates

• First Submitted: September 7, 2018
• First Submitted That Met QC Criteria: September 11, 2018
• First Posted (Actual): September 13, 2018

Study Record Updates

• Last Update Posted (Actual): March 20, 2020
• Last Update Submitted That Met QC Criteria: March 19, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Wounds and Injuries; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer; Crush Injuries; Pressure Ulcer
• Other Study ID Numbers: HC1801

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No