Back to resultsA Case Series Study of Negative Pressure Platform Wound Device (NP-PWD)
Primary Purpose
Incisions, Surgical
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NP-PWD
Sponsored by
About this trial
This is an interventional treatment trial for Incisions, Surgical
Eligibility Criteria
Inclusion Criteria:
- Patients 18-85 years of age.
- Scheduled for surgical intervention in which an incision will be made and skin closure will be performed.
Exclusion Criteria:
- 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
Sites / Locations
- Northeast Baptist
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NP-PWD application
Arm Description
All patients enrolled into the study will have the negative pressure- platform wound device applied to their surgical incision.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04080011
Brief Title
A Case Series Study of Negative Pressure Platform Wound Device
Acronym
NP-PWD
Official Title
A Case Series Study of Negative Pressure Platform Wound Device (NP-PWD) on the Healing of Elective Surgical Incisions
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
August 30, 2019 (Actual)
Primary Completion Date
December 5, 2019 (Actual)
Study Completion Date
December 11, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Metis Foundation
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incisions, Surgical
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NP-PWD application
Arm Type
Experimental
Arm Description
All patients enrolled into the study will have the negative pressure- platform wound device applied to their surgical incision.
Intervention Type
Device
Intervention Name(s)
NP-PWD
Intervention Description
Application of NP-PWD device.
Primary Outcome Measure Information:
Title
Incidence of treatment-related adverse events.
Description
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.
Time Frame
Three to six days post application.
Title
Rate of successful application of the NP-PWD device
Description
Descriptive data collected: device application, device removal, adverse device effects, device errors, device complications, and resultant in healing status of the surgical incision.
Time Frame
Three to fourteen days post application
Secondary Outcome Measure Information:
Title
Incidence of treatment-related adverse events.
Description
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.
Time Frame
Fourteen days post application.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients 18-85 years of age.
Scheduled for surgical intervention in which an incision will be made and skin closure will be performed.
Exclusion Criteria:
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
Facility Information:
Facility Name
Northeast Baptist
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
12. IPD Sharing Statement
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A Case Series Study of Negative Pressure Platform Wound Device
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