Evaluating Clinical Acceptance of a NPWT Wound Care System

NCT ID: NCT03670225

Last Updated: 2020-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-16
• Study Completion Date: 2020-01-30

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

Conditions

Diabetic Foot Ulcer; Pressure Injury; Pressure Ulcer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Invia Motion Endure

Group Type: OTHER

Invia Motion Endure

Intervention Type: DEVICE

NPWT Invia Motion Endure

Interventions

Invia Motion Endure

NPWT Invia Motion Endure

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Joseph M. Still Research Foundation, Inc.

OTHER

Sponsor Role: collaborator

Medela AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert F Mullins, MD

Role: PRINCIPAL_INVESTIGATOR

Joseph M. Still Research Foundation

Locations

Joseph M. Still Research Foundation

Augusta, Georgia, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 19903300 (View on PubMed)

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

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

Other Identifiers

HC1801

Identifier Type: -

Identifier Source: org_study_id