A Case Series Study of Negative Pressure Platform Wound Device

NCT04080011 | Completed FDA Device

• 1 other identifier: NP-PWD 01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Incisions, Surgical

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Incidence of treatment-related adverse events.

  Fourteen days post application.

Study Arms (1)

NP-PWD application

EXPERIMENTAL

All patients enrolled into the study will have the negative pressure- platform wound device applied to their surgical incision.

Device: NP-PWD

Interventions

NP-PWD DEVICE

Application of NP-PWD device.

NP-PWD application

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The Metis Foundation: lead

Study Sites (1)

Northeast Baptist

San Antonio, Texas, 78217, United States

Location

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: September 6, 2019
• Study Start: August 30, 2019
• Primary Completion: December 5, 2019
• Study Completion: December 11, 2019
• Last Updated: February 10, 2021

Record last verified: 2021-02

Locations

US (1)