A Case Series Study of Negative Pressure Platform Wound Device (NP-PWD)

A Case Series Study of Negative Pressure Platform Wound Device (NP-PWD) on the Healing of Elective Surgical Incisions

This primary case series study will demonstrate the safety and feasibility of the NP-PWD technology and treatment protocol to promote healing of surgical incision healing. In a first use in humans of the NP-PWD's capability to deliver negative pressure wound treatment (NPWT), this project will gather data from patients with elective surgical incisions, with the intention to evaluate the NPWT capability for future use in more tenuous situations of wound closure.

Study Overview

• Status: Completed
• Conditions: Incisions, Surgical
• Intervention / Treatment: Device: NP-PWD

Detailed Description

A case series study of 10 subjects will be conducted by enrolling patients who are scheduled for elective surgical incisions. Patients will be screened for inclusion criteria and asked to consent to participate in the study for single application treatment with the NP-PWD for 3-6 days. Initial evaluation of the incision would occur on Day 0, including screening, pre-procedure evaluation, measurement and photography of the closed surgical incision. Follow up data is then gathered Day 3-6 with removal of the NP-PWD, surgical incision assessment and photography, and assessment for adverse effects. Day 9-14 follow up include the same assessments of progression of wound closure. Gathered clinical data of the 10 subjects will be used to evaluate the safety in using the NPWT device for effective wound healing.

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

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78217
      • Northeast Baptist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients 18-85 years of age.
2. Scheduled for surgical intervention in which an incision will be made and skin closure will be performed.

Exclusion Criteria:

1. Active infection as judged by the Investigator
2. Inability to give informed consent
3. Active malignant disease or subject is less than one year disease-free
4. Use of immunosuppressive agents, radiation or chemotherapy within the past 30 days
5. Any concomitant medications or co-morbidities that, in the opinion of the investigator, may interfere with wound healing
6. On any investigational drug(s) or therapeutic device(s) in the last 30 days or any previous enrollment in this study
7. Pregnant at enrollment

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
Experimental: NP-PWD application; All patients enrolled into the study will have the negative pressure- platform wound device applied to their surgical incision.	Device: NP-PWD; Application of NP-PWD device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment-related adverse events.	Safety is assessed by recording each adverse event (AE) occurring during the period the patient has the study device applied and throughout the entire enrollment period.	Three to six days post application.
Rate of successful application of the NP-PWD device	Descriptive data collected: device application, device removal, adverse device effects, device errors, device complications, and resultant in healing status of the surgical incision.	Three to fourteen days post application

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment-related adverse events.	Safety is assessed by recording each adverse event (AE) occurring during the period the patient has the study device applied and throughout the entire enrollment period.	Fourteen days post application.

Collaborators and Investigators

• Sponsor: The Metis Foundation

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2019
• Primary Completion (Actual): December 5, 2019
• Study Completion (Actual): December 11, 2019

Study Registration Dates

• First Submitted: August 29, 2019
• First Submitted That Met QC Criteria: September 3, 2019
• First Posted (Actual): September 6, 2019

Study Record Updates

• Last Update Posted (Actual): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 8, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: NP-PWD 01

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.: Yes