A Case Series Study of Negative Pressure Platform Wound Device

NCT ID: NCT04080011

Last Updated: 2021-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-30
• Study Completion Date: 2019-12-11

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.

Conditions

Incisions, Surgical

Study Design

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

Study Groups

NP-PWD application

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

Group Type: EXPERIMENTAL

NP-PWD

Intervention Type: DEVICE

Application of NP-PWD device.

Interventions

NP-PWD

Application of NP-PWD device.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Metis Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Northeast Baptist

San Antonio, Texas, United States

Countries

United States

Other Identifiers

NP-PWD 01

Identifier Type: -

Identifier Source: org_study_id