A Case Series Study of Negative Pressure Platform Wound Device

Incisions, Surgical Clinical Trial

— NP-PWD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04080011
• Other study ID #: NP-PWD 01
• Status: Completed
• Phase: N/A
• Start date: August 30, 2019
• Est. completion date: December 11, 2019

Study information

• Verified date: February 2021
• Source: The Metis Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 11, 2019
• Est. primary completion date: December 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Incisions, Surgical
• Surgical Wound

Intervention

Device:
• NP-PWD
Application of NP-PWD device.

Locations

Country	Name	City	State
United States	Northeast Baptist	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The Metis Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.