A Case Series Study of Negative Pressure Platform Wound Device

Not Applicable

Completed

• Conditions: Incisions, Surgical
• Interventions: Device: NP-PWD

• Registration Number: NCT04080011
• Lead Sponsor: The Metis Foundation

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.

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 Timeline

• Study First Submitted: 2019-08-29
• Study Start: 2019-08-30
• Study First Submitted QC: 2019-09-03
• Study First Posted: 2019-09-06
• Primary Completion: 2019-12-05
• Study Completion: 2019-12-11
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-08
• Last Update Posted: 2021-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NP-PWD application	NP-PWD	All patients enrolled into the study will have the negative pressure- platform wound device applied to their surgical incision.

Primary Outcome Measures

Name	Time	Method
Incidence of treatment-related adverse events.	Three to six days post application.	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.
Rate of successful application of the NP-PWD device	Three to fourteen days post application	Descriptive data collected: device application, device removal, adverse device effects, device errors, device complications, and resultant in healing status of the surgical incision.

Secondary Outcome Measures

Name	Time	Method
Incidence of treatment-related adverse events.	Fourteen days post application.	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.

Trial Locations

Locations (1)

Northeast Baptist; 🇺🇸 San Antonio, Texas, United States